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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 K023757
Device Name CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
Applicant
Endocare, Inc.
201 Technology Dr.
Irvin,  CA  92618
Applicant Contact EBEN GORDON
Correspondent
Endocare, Inc.
201 Technology Dr.
Irvin,  CA  92618
Correspondent Contact EBEN GORDON
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received11/08/2002
Decision Date 12/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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