FDA 510(k) Application Details - K070625

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K070625
Device Name Mesh, Surgical, Polymeric
Applicant MARKETING SOLUTIONS INC.
8 ORANGE DR.
JERICHO, NY 11753 US
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Contact LORENA TRABUCCO
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 03/06/2007
Decision Date 08/01/2007
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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