FDA 510(k) Application Details - K033579

Device Classification Name Clip, Implantable, Reprocessed

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510(K) Number K033579
Device Name Clip, Implantable, Reprocessed
Applicant CLEAR MEDICAL, INC.
1776 136TH PL. NE
BELLEVUE, WA 98005 US
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Contact MIKE KOVACS
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Regulation Number 878.4300

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Classification Product Code NMJ
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Date Received 11/13/2003
Decision Date 07/11/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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