EASYBELL


Device Classification Name

biopsy needle kit

510(k) Number K011075
Device Name EASYBELL
Original Applicant
BIOPSYBELL S.A.S.
131 highwood dr.
south glastonbury, 
CT 
06073

Original Contact lucio improta
Regulation Number 876.1075
Classification Product Code
FCG  
Date Received 04/09/2001
Decision Date 06/27/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No