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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 K050272
Device Name CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
Applicant
Cryomedical Instruments, Ltd.
Grove Way
Mansfield Woodhouse
Mansfield,  GB NG19 8BW
Applicant Contact GARETH COPPING
Correspondent
Cryomedical Instruments, Ltd.
Grove Way
Mansfield Woodhouse
Mansfield,  GB NG19 8BW
Correspondent Contact GARETH COPPING
Regulation Number882.4250
Classification Product Code
GXH  
Date Received02/04/2005
Decision Date 03/24/2005
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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