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510(k) K161991

Curasite by Izun Pharmaceuticals — Product Code FRO

K161991 is an FDA 510(k) premarket notification submitted by Izun Pharmaceuticals for the device "Curasite". The FDA issued a decision of Substantially Equivalent on Mar 3, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 3, 2017
Date Received
Jul 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

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FDA data resources