TOPCUT


Device Classification Name

biopsy needle kit

510(k) Number K021525
Device Name TOPCUT
Original Applicant
H.S. HOSPITAL SERVICE S.R.L.
10147 umberland place
boca raton, 
FL 
33428

Original Contact lucio improta
Regulation Number 876.1075
Classification Product Code
FCG  
Date Received 05/10/2002
Decision Date 07/12/2002
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