MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K021211
Device Name MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM
Original Applicant
SANARUS MEDICAL, INC.
5880 west las positas,suite 52
pleasanton, 
CA 
94588

Original Contact vincent cutarelli
Regulation Number 878.4350
Classification Product Code
GEH  
Date Received 04/17/2002
Decision Date 06/26/2002
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