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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact MIKE HAAS, M.D.
Regulation Number878.4350
Classification Product Code
GEH  
Date Received03/18/2011
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
Predetermined Change
Control Plan Authorized		 No
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