FDA 510(k) Application Details - K052018

Device Classification Name Clip, Implantable

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510(K) Number K052018
Device Name Clip, Implantable
Applicant MILTEX, INC.
589 DAVIES DRIVE
YORK, PA 17402 US
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Contact CHARLES WEAVER
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 07/26/2005
Decision Date 11/04/2005
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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