POLAR WAND


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K021387
Device Name POLAR WAND
Original Applicant
CHEK-MED SYSTEMS
25 village hill rd.
willington, 
CT 
06279

Original Contact rob whalen
Regulation Number 878.4350
Classification Product Code
GEH  
Date Received 05/02/2002
Decision Date 07/31/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No