FDA 510(k) Application Details - K982313

Device Classification Name Clip, Implantable

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510(K) Number K982313
Device Name Clip, Implantable
Applicant WECK CLOSURE SYSTEMS
1 WECK DR.
RESEARCH TRIANGLE PARK, NC 27709 US
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Contact BRIAN YOUNG
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 07/01/1998
Decision Date 08/10/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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