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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 K963970
Device Name ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM
Applicant
Endocare, Inc.
18 Technology Dr., Suite 134
Irvine,  CA  92718
Applicant Contact VIN CUTARELLI
Correspondent
Endocare, Inc.
18 Technology Dr., Suite 134
Irvine,  CA  92718
Correspondent Contact VIN CUTARELLI
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
KOE  
Date Received10/03/1996
Decision Date 02/25/1997
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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