SI ASCOPE


Device Classification Name

light, surgical, floor standing

510(k) Number K011273
Device Name SI ASCOPE
Original Applicant
ASTRON CLINICA LIMITED
po box 4341
crofton, 
MD 
21114

Original Contact e.j. smith
Regulation Number 878.4580
Classification Product Code
FSS  
Date Received 04/26/2001
Decision Date 02/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No