HET BIPOLAR LIGATOR SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K121085
Device Name HET BIPOLAR LIGATOR SYSTEM
Applicant
HET SYSTEMS, LLC
1152 navarro st, ste 2001
santa rosa, 
CA 
95401

Applicant Contact shelley trimm
Correspondent
HET SYSTEMS, LLC
1152 navarro st, ste 2001
santa rosa, 
CA 
95401

Correspodent Contact shelley trimm
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 04/10/2012
Decision Date 11/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No