FDA 510(k) Application Details - K964109

Device Classification Name Clip, Implantable

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510(K) Number K964109
Device Name Clip, Implantable
Applicant MICROSURGE, INC.
150 A ST.
NEEDHAM, MA 02194 US
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Contact RICHARD LARIVIERE
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 10/15/1996
Decision Date 11/27/1996
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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