FDA 510(k) Application Details - K040621

Device Classification Name Mesh, Surgical

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510(K) Number K040621
Device Name Mesh, Surgical
Applicant ACELL, INC
5610 WISCONSIN AVE
#304
CHEVY CHASE, MD 20815 US
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Contact PATSY J TRISLER
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 03/09/2004
Decision Date 04/14/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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