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510(k) K120730

LOUTREX TOPICAL CREAM by Acella Pharmaceuticals, LLC — Product Code FRO

K120730 is an FDA 510(k) premarket notification submitted by Acella Pharmaceuticals, LLC for the device "LOUTREX TOPICAL CREAM". The FDA issued a decision of Substantially Equivalent on September 6, 2012. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2012
Date Received
March 9, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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FDA data resources