FDA 510(k) Application Details - K111930

Device Classification Name Clip, Implantable

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510(K) Number K111930
Device Name Clip, Implantable
Applicant ACKERMANN INSTRUMENTE GMBH
8202 SHERMAN ROAD
CHESTERLAND, OH 44026-2141 US
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Contact KAREN E WARDEN, PHD
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 07/07/2011
Decision Date 11/08/2011
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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