FDA 510(k) Application Details - K971745

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K971745
Device Name Mesh, Surgical, Polymeric
Applicant DAVOL, INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON, RI 02920 US
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Contact JEANNETTE G CLOUTIER
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 05/12/1997
Decision Date 08/06/1997
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

FDA Source Information for K971745


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