PAJUNK’S PRIMOCUT DISPOSABLE BIOPSY SYSTEM


Device Classification Name

device, percutaneous, biopsy

510(k) Number K080674
Device Name PAJUNK’S PRIMOCUT DISPOSABLE BIOPSY SYSTEM
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 878.4800
Classification Product Code
MJG  
Date Received 03/10/2008
Decision Date 05/09/2008
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