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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 K050347
Device Name MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
Applicant
ENDOCARE, INC.
201 TECHNOLOGY DR.
IRVINE,  CA  92618
Applicant Contact EBEN GORDON
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Codes
ITX   IYN   OCL  
Date Received02/11/2005
Decision Date 02/25/2005
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
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