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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 K973686
Device Name ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM
Applicant
ENDOCARE, INC.
7 STUDEBAKER
IRVINE,  CA  92618
Applicant Contact VIN CUTARELLI
Correspondent
ENDOCARE, INC.
7 STUDEBAKER
IRVINE,  CA  92618
Correspondent Contact VIN CUTARELLI
Regulation Number878.4350
Classification Product Code
GEH  
Date Received09/26/1997
Decision Date 12/22/1997
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
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