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FDA 510(k) Application Details - K010447
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K010447
Device Name
Dressing, Wound, Drug
Applicant
WESTAIM BIOMEDICAL, INC.
ONE HAMPTON RD. SUITE 302
EXETER, NH 03833 US
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Contact
Steve Chartier
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
02/13/2001
Decision Date
03/15/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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