FDA 510(k) Application Details - K241250

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K241250
Device Name Mesh, Surgical, Polymeric
Applicant Davol Inc., Subsidiary of C.R. Bard, Inc.
100 Crossings Boulevard
Warwick, RI 02886 US
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Contact Richard Spaziano
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 05/03/2024
Decision Date 06/14/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241250


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