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FDA 510(k) Application Details - K140483
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K140483
Device Name
Dressing, Wound, Drug
Applicant
ABL MEDICAL, LLC
400 N. WASHINGTON ST., STE 100
ALEXANDRIA, VA 22314 US
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Contact
Calley Herzog
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
02/26/2014
Decision Date
05/20/2014
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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