VACUFLASH BIOPSY SYSTEM


Device Classification Name

instrument, biopsy

510(k) Number K024089
Device Name VACUFLASH BIOPSY SYSTEM
Original Applicant
BIP USA, INC.
345 third st., suite 400
niagara falls, 
NY 
14303

Original Contact siegfried gruchot
Regulation Number 876.1075
Classification Product Code
KNW  
Date Received 12/11/2002
Decision Date 03/11/2003
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