FDA 510(k) Application Details - K022854

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K022854
Device Name Dressing, Wound, Collagen
Applicant ACELL, INC
815 CONNECTICUT AVE NW
SUITE 800
WASHINGTON, DC 20006 US
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Contact PATSY J TRISLER
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 08/15/2002
Decision Date 12/30/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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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