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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 K060279
Device Name CRYOCARE CS SURGICAL SYSTEM
Applicant
Endocare, Inc.
201 Technology Dr.
Irvin,  CA  92618
Applicant Contact ALDEN KAY
Correspondent
Endocare, Inc.
201 Technology Dr.
Irvin,  CA  92618
Correspondent Contact ALDEN KAY
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received02/02/2006
Decision Date 02/28/2006
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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