FDA 510(k) Application Details - K011514

Device Classification Name Kit, Surgical Instrument, Disposable

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510(K) Number K011514
Device Name Kit, Surgical Instrument, Disposable
Applicant KENCAP LTD.
247 MARGARET KING AVE.
RINGWOOD, NJ 07456 US
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Contact MARTY DELIN
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Regulation Number 878.4800

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Classification Product Code KDD
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Date Received 05/17/2001
Decision Date 08/13/2001
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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