FDA 510(k) Application Details - K080353

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K080353
Device Name Mesh, Surgical, Polymeric
Applicant LIFECELL CORP.
ONE MILLENNIUM WAY
BRANCHBURG, NJ 08876 US
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Contact LORRAINE T MONTEMURRO
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 02/11/2008
Decision Date 04/03/2008
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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