FDA 510(k) Application Details - K050272

Device Classification Name Device, Surgical, Cryogenic

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510(K) Number K050272
Device Name Device, Surgical, Cryogenic
Applicant CRYOMEDICAL INSTRUMENTS, LTD.
GROVE WAY
MANSFIELD WOODHOUSE
MANSFIELD NG19 8BW GB
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Contact GARETH COPPING
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Regulation Number 882.4250

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Classification Product Code GXH
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Date Received 02/04/2005
Decision Date 03/24/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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