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FDA 510(k) Application Details - K100580
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K100580
Device Name
Dressing, Wound, Drug
Applicant
EXCITON TECHNOLOGIES INC.
SUITE 4232, 10230 JASPER AVE
EDMONTON, ALBERTA T5J 4P6 CA
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Contact
JOHN SIMON
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
03/02/2010
Decision Date
10/12/2010
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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