FDA 510(k) Application Details - K982330

Device Classification Name Mesh, Surgical

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510(K) Number K982330
Device Name Mesh, Surgical
Applicant DEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW, IN 46581-0988 US
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Contact CHERYL K HASTINGS
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 07/02/1998
Decision Date 09/25/1998
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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