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FDA 510(k) Application Details - K070333
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K070333
Device Name
Dressing, Wound, Drug
Applicant
ACRYMED, INC.
9560 SW NIMBUS AVE
BEAVERTON, OR 97008 US
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Contact
BRUCE GIBBONS
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/05/2007
Decision Date
07/10/2007
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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