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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Surgical, Cryogenic
510(k) Number K031482
Device Name CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE
Applicant
Cryomedical Instruemts , Ltd.
Cryomed House, Grove Way
Mansfield Woodhouse, Notts,  GB NG19 8BW
Applicant Contact GARETH COPPING
Correspondent
Cryomedical Instruemts , Ltd.
Cryomed House, Grove Way
Mansfield Woodhouse, Notts,  GB NG19 8BW
Correspondent Contact GARETH COPPING
Regulation Number882.4250
Classification Product Code
GXH  
Date Received05/12/2003
Decision Date 07/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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