FDA 510(k) Application Details - K092926

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K092926
Device Name Dressing, Wound, Collagen
Applicant ACELL, INC
8671 ROBERT FULTON DRIVE
SUITE B
COLUMBIA, MD 21046 US
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Contact RODNEY W BOSLEY
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 09/23/2009
Decision Date 10/28/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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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