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FDA 510(k) Application Details - K052536
Device Classification Name
Dressing, Wound, Drug
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510(K) Number
K052536
Device Name
Dressing, Wound, Drug
Applicant
DERMA SCIENCES CANADA, INC.
104 SHORTING RD.
TORONTO, ONTARIO M1S 3S4 CA
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Contact
DELA SHARMINI ATHERAY
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/15/2005
Decision Date
09/13/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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