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FDA 510(k) Application Details - K081782
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K081782
Device Name
Dressing, Wound, Collagen
Applicant
INNOCOLL PHARMACEUTICALS
DUBLIN ROAD
ATHLONE, CO. WESTMEATH IE
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Contact
AARON WYSE
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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
06/23/2008
Decision Date
09/30/2008
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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