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

Cannula, Surgical, General & Plastic Surgery (GEA) (10)

Premarket Exempt

Yes No

Clear

HK Infiltration Microcannula, 3"-16 gauge - 00816989020225 Catalog Number : IC16x8

Device Description : HK Infiltration Microcannula, 3"-16 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Infiltration Microcannula, 4"-16 gauge - 00816989020232 Catalog Number : IC16x10

Device Description : HK Infiltration Microcannula, 4"-16 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Infiltration Microcannula, 6"-16 gauge - 00816989020249 Catalog Number : IC16x15

Device Description : HK Infiltration Microcannula, 6"-16 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Infiltration Microcannula, 3"-18 gauge - 00816989020256 Catalog Number : IC18x8

Device Description : HK Infiltration Microcannula, 3"-18 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Infiltration Microcannula, 4"-18 gauge - 00816989020263 Catalog Number : IC18x10

Device Description : HK Infiltration Microcannula, 4"-18 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Infiltration Microcannula, 8" (20cm) -18 gauge - 00816989020270 Catalog Number : IC18x20

Device Description : HK Infiltration Microcannula, 8" (20cm) -18 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Monty Infiltration Cannula, 8"-14 gauge Tip Monty - 00816989020287 Catalog Number : IC14TM20

Device Description : HK Monty Infiltration Cannula, 8"-14 gauge Tip Monty

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Monty Infiltration Cannula, 8"-14 gauge Half Monty - 00816989020294 Catalog Number : IC14HM20

Device Description : HK Monty Infiltration Cannula, 8"-14 gauge Half Monty

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Monty Infiltration Cannula, 8"-14 gauge Full Monty - 00816989020300 Catalog Number : IC14FM20

Device Description : HK Monty Infiltration Cannula, 8"-14 gauge Full Monty

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Monty Infiltration Cannula, 6"-16 gauge Tip Monty - 00816989020317 Catalog Number : IC16TM15

Device Description : HK Monty Infiltration Cannula, 6"-16 gauge Tip Monty

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

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