FDA 510(k) Application Details - K003323

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K003323
Device Name Mesh, Surgical, Polymeric
Applicant DAVOL, INC.
SUBSIDIARY OF C.R. BARD
100 SOCKANOSSETT CROSSROAD
CRANSTON, RI 02920 US
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Contact PAULA E BULGER
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 10/24/2000
Decision Date 01/22/2001
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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