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510(k) K132329

NIVATOPIC PLUS by Nivagen Pharmaceuticals, Inc. — Product Code FRO

K132329 is an FDA 510(k) premarket notification submitted by Nivagen Pharmaceuticals, Inc. for the device "NIVATOPIC PLUS". The FDA issued a decision of Substantially Equivalent on December 20, 2013. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2013
Date Received
July 26, 2013
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