FDA 510(k) Application Details - K100076

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K100076
Device Name Mesh, Surgical, Polymeric
Applicant ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON, NH 03051 US
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Contact Jacqueline Emery
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 01/12/2010
Decision Date 01/26/2010
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



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