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

Accessories, Catheter (KGZ) (9) Tubing, Noninvasive (GAZ) (1)

Premarket Exempt

No Yes

Clear

Fine Touch Aspiration Tubing - 38169890200020 Catalog Number : ATF-20

Device Description : FINE TOUCH ASPIRATION TUBING

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 20

HK CV Single Spike Infiltration Tubing - 38169890200037 Catalog Number : CVT-10

Device Description : CV INFILTRATION TUBING SET

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 10

HK CV Single Spike Infiltration Tubing - Vascular Solutions - 38169890200044 Catalog Number : CVT-10VS

Device Description : CV INFILTRATION TUBING SET

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 10

HK CV Single Spike Infiltration Tubing - 38169890200051 Catalog Number : CVT-20

Device Description : CV INFILTRATION TUBING SET

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 20

HK CV Single Spike Infiltration Tubing - Vascular Solutions - 38169890200068 Catalog Number : CVT-20VS

Device Description : CV INFILTRATION TUBING SET

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 20

HK 2X Infiltration Tubing - 38169890200075 Catalog Number : IT2X-10

Device Description : INFILTRATION TUBING SET

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 10

Double Spike Infiltration Tubing - 38169890200082 Catalog Number : ITD-20

Device Description : INFILTRATION TUBING SET

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 20

Single Spike Infiltration Tubing - 38169890200099 Catalog Number : ITS-10

Device Description : INFILTRATION TUBING SET

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 10

Single Spike Infiltration Tubing - ReShape - 38169890200105 Catalog Number : ITS-10-RS

Device Description : KLEIN INFILTRATION SET

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 10

Single Spike Infiltration Tubing - 38169890200112 Catalog Number : ITS-20

Device Description : INFILTRATION TUBING SET

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 20

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