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FDA 510(k) Application Details - K100927
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K100927
Device Name
Dressing, Wound, Collagen
Applicant
MAXIGEN BIOTECH, INC.
2904 N BOLDT AVE
FLAGSTAFF, AZ 86001 US
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Contact
JENNIFER REICH
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KGN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/05/2010
Decision Date
02/02/2011
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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