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

Pump, Infusion (FRN) (4) Tubing, Noninvasive (GAZ) (3) System, Suction, Lipoplasty (MUU) (2) Accessories, Catheter (KGZ) (1)

Premarket Exempt

No Yes

Clear

Klein Tumescent Infiltration Pump - 00816989021123 Catalog Number : KTIP

Device Description : Klein Tumescent Infiltration Pump

Device Class : 2

Duns Number: 106885259

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Klein Infiltration Pump II - 08169890200128 Catalog Number : KIP-II

Device Description : Klein Infiltration Pump II

Device Class : 2

Duns Number: 106885259

Premarket Exempt : No

Product Code : FRN

Prescription Use : No

Device Count : 1

ReShape Infiltration Pump - 08169890200135 Catalog Number : KIP-II-RS

Device Description : ReShape Infiltration Pump

Device Class : 2

Duns Number: 106885259

Premarket Exempt : No

Product Code : FRN

Prescription Use : No

Device Count : 1

Klein Touch Pump - 08169890200142 Catalog Number : KTP

Device Description : Klein Touch Pump

Device Class : 2

Duns Number: 106885259

Premarket Exempt : No

Product Code : FRN

Prescription Use : No

Device Count : 1

HK Aspirator Pump 115V - 08169890200159 Catalog Number : AP-III

Device Description : HK Aspirator Pump 115V

Device Class : 2

Duns Number: 106885259

Premarket Exempt : No

Product Code : MUU

Prescription Use : No

Device Count : 1

HK Aspirator Pump 230 V - 08169890200166 Catalog Number : AP-230III

Device Description : HK Aspirator Pump 230 V

Device Class : 2

Duns Number: 106885259

Premarket Exempt : No

Product Code : MUU

Prescription Use : No

Device Count : 1

Heavy Aspiraton Tubing - 30816989020004 Catalog Number : AT375

Device Description : ASPIRATION TUBING SET

Device Class :

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 10

Aspiration Tubing - 30816989020011 Catalog Number : AT6-10

Device Description : ASPIRATION TUBING SET

Device Class : 2

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 10

Fine Touch Aspiration Tubing - 30816989020028 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 - 30816989020035 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

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