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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 K032333
Device Name CRYOCARE CS SURGICAL SYSTEM
Applicant
Endocare, Inc.
201 Technology Dr.
Irvin,  CA  92618
Applicant Contact EBEN GORDON
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact LAURA DANIELSON
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Codes
ITX   IYN   IYO   OCL  
Date Received07/29/2003
Decision Date 08/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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