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510(k) K170911

NEOCERA Advanced Barrier Cream by Exeltis USA Dermatology, LLC — Product Code FRO

K170911 is an FDA 510(k) premarket notification submitted by Exeltis USA Dermatology, LLC for the device "NEOCERA Advanced Barrier Cream". The FDA issued a decision of Substantially Equivalent on Aug 22, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 22, 2017
Date Received
Mar 28, 2017
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