HK SURGICAL INC.

Address:1271 PUERTA DEL SOL,SAN CLEMENTE,CA,92673,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Fiber, Medical, Absorbent (FRL) (6) Cannula, Surgical, General & Plastic Surgery (GEA) (4)

Premarket Exempt

No Yes

Clear

HK Tumescent Infiltration Cannula Tip Monty, (15cm) 6"-18 gauge, Single Use, Box - 00816989021000 Catalog Number : SU-IC18TM15

Device Description : HK Tumescent Infiltration Cannula Tip Monty, (15cm) 6"-18 gauge, Single Use, Box of 10

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 10

HK Tumescent Infiltration Cannula, (10cm) 4"-18 gauge, Single Use, Box of 10 - 00816989021017 Catalog Number : SU-IC18x10

Device Description : HK Tumescent Infiltration Cannula, (10cm) 4"-18 gauge, Single Use, Box of 10

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 10

HK Tumescent Infiltration Cannula, (20cm) 8" -18 gauge, Single Use, Box of 10 - 00816989021024 Catalog Number : SU-IC18x20

Device Description : HK Tumescent Infiltration Cannula, (20cm) 8" -18 gauge, Single Use, Box of 10

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 10

HK Tumescent Infiltration Cannula, (8cm) 3"-18 gauge, Single Use, Box of 10 - 00816989021031 Catalog Number : SU-IC18x8

Device Description : HK Tumescent Infiltration Cannula, (8cm) 3"-18 gauge, Single Use, Box of 10

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 10

HK Non-Sterile Super Absorbent Pads X-Small - 00816989021048 Catalog Number : PD-XS

Device Description : HK Non-Sterile Super Absorbent Pads X-Small

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 48

HK Non-Sterile Super Absorbent Pads Small - 00816989021055 Catalog Number : PD-S

Device Description : HK Non-Sterile Super Absorbent Pads Small

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 48

HK Non-Sterile Super Absorbent Pads Medium - 00816989021062 Catalog Number : PD-M

Device Description : HK Non-Sterile Super Absorbent Pads Medium

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 48

HK Non-Sterile Super Absorbent Pads Large - 00816989021079 Catalog Number : PD-L

Device Description : HK Non-Sterile Super Absorbent Pads Large

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 48

HK Non-Sterile Super Absorbent Pads Rectangle - 00816989021086 Catalog Number : PD-R

Device Description : HK Non-Sterile Super Absorbent Pads Rectangle

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 48

HK Non-Sterile Super Absorbent Pads XL - 00816989021093 Catalog Number : PD-XL

Device Description : HK Non-Sterile Super Absorbent Pads XL

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 48

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