SILENT BIOPSY NEEDLE


information about

Device Classification Name

biopsy needle kit

510(k) Number K002946
Device Name SILENT BIOPSY NEEDLE
Original Applicant
H.S. HOSPITAL SERVICE S.R.L.
131 highway dr.
south glastonbury, 
CT 
06073

Original Contact lucio improta
Regulation Number 876.1075
Classification Product Code
FCG  
Date Received 09/21/2000
Decision Date 12/19/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No