SURGICAL SYSTEM WITH CRYOGUIDE


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K002615
Device Name SURGICAL SYSTEM WITH CRYOGUIDE
Original Applicant
ENDOCARE, INC.
7 studebaker
irvine, 
CA 
92618

Original Contact vincent cutarelli
Regulation Number 878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received 08/22/2000
Decision Date 11/13/2000
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