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FDA 510(k) Application Details - K022854
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
KGN
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More FDA Info for this Product Code
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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