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FDA 510(k) Application Details - K093544
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K093544
Device Name
Dressing, Wound, Drug
Applicant
MIDLOTHIAN LABORATORIES
760 INDUSTRIAL PARK BLVD.
UNIT C
MONTGOMERY, AL 36117 US
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Contact
BRYCE HARVEY
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
11/17/2009
Decision Date
02/16/2010
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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