GENICON CLIP APPLIER


Device Classification Name

clip, implantable

510(k) Number K030269
Device Name GENICON CLIP APPLIER
Original Applicant
GENICON, LC
p.o. box 780038
orlando, 
FL 
32878 -0038

Original Contact frank goldfarb
Regulation Number 878.4300
Classification Product Code
FZP  
Subsequent Product Code
GDO  
Date Received 01/27/2003
Decision Date 03/20/2003
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