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510(k) K200641

HaloGUARD Protective Disc with CHG by Attwill Medical Solutions — Product Code FRO

K200641 is an FDA 510(k) premarket notification submitted by Attwill Medical Solutions for the device "HaloGUARD Protective Disc with CHG". The FDA issued a decision of Substantially Equivalent on Sep 3, 2020. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 3, 2020
Date Received
Mar 11, 2020
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