PAJUNK’S KIT FOR BALLOON AIDED LAPAROSCOPY


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K080654
Device Name PAJUNK’S KIT FOR BALLOON AIDED LAPAROSCOPY
Applicant
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-strasse 01
geisingen, baden-wurttemberg, 

DE

78187

Applicant Contact christian quass
Correspondent
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-strasse 01
geisingen, baden-wurttemberg, 

DE

78187

Correspodent Contact christian quass
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 03/07/2008
Decision Date 05/08/2008
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