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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 K964971
Device Name CRYOGEN CRYOSURGICAL SYSTEM
Applicant
Cryogen, Inc.
6199 Cornerstone Ct. E.
Suite 106
San Diego,  CA  92121
Applicant Contact JOHN DOBAK
Correspondent
Cryogen, Inc.
6199 Cornerstone Ct. E.
Suite 106
San Diego,  CA  92121
Correspondent Contact JOHN DOBAK
Regulation Number878.4350
Classification Product Code
GEH  
Date Received12/12/1996
Decision Date 03/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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