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FDA 510(k) Application Details - K061746
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K061746
Device Name
Dressing, Wound, Collagen
Applicant
INNOCOLL PHARMACEUTICALS
IDA BUSINESS AND TECHNOLOGY
PARK, GARRYCASTLE
ATHLONE, CO. WESTMEATH IE
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Contact
AARON WYSE
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KGN
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More FDA Info for this Product Code
Date Received
06/21/2006
Decision Date
10/02/2006
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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