FDA 510(k) Application Details - K962043

Device Classification Name Clip, Implantable

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510(K) Number K962043
Device Name Clip, Implantable
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact VICTOR CLAVELLI
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 05/28/1996
Decision Date 09/23/1996
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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