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510(k) K180305

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) by Aquilabs Us, LLC — Product Code FRO

K180305 is an FDA 510(k) premarket notification submitted by Aquilabs Us, LLC for the device "Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)". The FDA issued a decision of Substantially Equivalent on Apr 13, 2018. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 13, 2018
Date Received
Feb 2, 2018
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