GENICON LAPAROSCOPES


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K030174
Device Name GENICON LAPAROSCOPES
Original Applicant
GENICON, LC
p.o. box 780038
orlando, 
FL 
32878 -0038

Original Contact gary haberland
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 01/17/2003
Decision Date 06/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No