BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES


Device Classification Name

biopsy needle kit

510(k) Number K021847
Device Name BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES
Original Applicant
BIOPSY SCIENCES, LLC
5582 chalon rd.
yorba linda, 
CA 
92886

Original Contact sharon rockwell
Regulation Number 876.1075
Classification Product Code
FCG  
Date Received 06/05/2002
Decision Date 09/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No