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FDA 510(k) Application Details - K120730
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K120730
Device Name
Dressing, Wound, Drug
Applicant
ACELLA PHARMACEUTICALS, LLC
248 LATITUDE LANE
SUITE 104
LAKE WYLIE, SC 29710 US
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Contact
LARA NOAH
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Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
03/09/2012
Decision Date
09/06/2012
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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