CRYOPEN CRYOSURGICAL SYSTEM, K102214


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K110754
Device Name CRYOPEN CRYOSURGICAL SYSTEM, K102214
Applicant
CRYOPEN, INC.
577 commerce st
suite b
southlake, 
TX 
76092

Applicant Contact mike haas, m.d.
Correspondent
CRYOPEN, INC.
577 commerce st
suite b
southlake, 
TX 
76092

Correspodent Contact mike haas, m.d.
Regulation Number 878.4350
Classification Product Code
GEH  
Date Received 03/18/2011
Decision Date 09/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No