CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K023757
Device Name CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
Original Applicant
ENDOCARE, INC.
201 technology dr.
irvine, 
CA 
92618

Original Contact eben gordon
Regulation Number 878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received 11/08/2002
Decision Date 12/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls