FDA 510(k) Application Details - K132658

Device Classification Name Clip, Implantable

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510(K) Number K132658
Device Name Clip, Implantable
Applicant TELEFLEX MEDICAL
2917 WECK DR.
RESEARCH TRIANGLE PARK, NC 27709 US
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Contact ASHLEA RICCI, RAC
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 08/26/2013
Decision Date 11/27/2013
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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