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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 K101333
Device Name CRYOCARE CS SURGICAL SYSTEM
Applicant
ENDOCARE, INC.
9825 SPECTRUM DRIVE
BLDG 2
AUSTIN,  TX  78717
Applicant Contact DEVONNE PAVLAK
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number878.4350
Classification Product Code
GEH  
Date Received05/12/2010
Decision Date 06/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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