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) (7) Cannula, Surgical, General & Plastic Surgery (GEA) (3)

Premarket Exempt

No Yes

Clear

HK Sterile Super Absorbent Pads X-Small - 00816989020799 Catalog Number : SPD-XS

Device Description : HK Sterile Super Absorbent Pads X-Small

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 48

HK Sterile Super Absorbent Pads Small - 00816989020805 Catalog Number : SPD-S

Device Description : HK Sterile Super Absorbent Pads Small

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 48

HK Sterile Super Absorbent Pads Medium - 00816989020812 Catalog Number : SPD-M

Device Description : HK Sterile Super Absorbent Pads Medium

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 48

HK Sterile Super Absorbent Pads Large - 00816989020829 Catalog Number : SPD-L

Device Description : HK Sterile Super Absorbent Pads Large

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 48

HK Sterile Super Absorbent Pads XL - 00816989020836 Catalog Number : SPD-XL

Device Description : HK Sterile Super Absorbent Pads XL

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 48

HK Sterile Super Absorbent OR Table Sheet 31"x 48" - 00816989020843 Catalog Number : SPD-OR3148

Device Description : HK Sterile Super Absorbent OR Table Sheet 31"x 48"

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 20

HK Sterile Super Absorbent OR Table Sheet 31" x 71" - 00816989020850 Catalog Number : SPD-OR3171

Device Description : HK Sterile Super Absorbent OR Table Sheet 31" x 71"

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 20

HK Tumescent Infiltration Cannula, (15cm) 6"-12 gauge, Single Use, Box of 10 - 00816989020874 Catalog Number : SU-IC12x15

Device Description : HK Tumescent Infiltration Cannula, (15cm) 6"-12 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, (23cm) 9"-12 gauge, Single Use, Box of 10 - 00816989020881 Catalog Number : SU-IC12x23

Device Description : HK Tumescent Infiltration Cannula, (23cm) 9"-12 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, (27cm) 11"-12 gauge, Single Use, Box of 10 - 00816989020898 Catalog Number : SU-IC12x27

Device Description : HK Tumescent Infiltration Cannula, (27cm) 11"-12 gauge, Single Use, Box of 10

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 10

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