FDA 510(k) Application Details - K152081

Device Classification Name Clip, Implantable

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510(K) Number K152081
Device Name Clip, Implantable
Applicant Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville, NC 27560 US
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Contact Ashlea Ricci
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 07/27/2015
Decision Date 08/26/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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