FDA 510(k) Application Details - K070323

Device Classification Name Clamp, Vascular

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510(K) Number K070323
Device Name Clamp, Vascular
Applicant VASCUTEK LTD.
NEWMAINS AVE.
INCHINNAN INDUSTRIAL ESTATE
RENFREWSHIRE,GLASGOW,SCOTLAND PA4 9RR GB
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Contact KAREN KELSO
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 02/02/2007
Decision Date 02/15/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review Y



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