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510(k) K183681

Protego Antimicrobial Wound Dressing by Global Health Solutions (Dba Turn Therapeutics) — Product Code FRO

K183681 is an FDA 510(k) premarket notification submitted by Global Health Solutions (Dba Turn Therapeutics) for the device "Protego Antimicrobial Wound Dressing". The FDA issued a decision of Substantially Equivalent on Oct 11, 2019. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 11, 2019
Date Received
Dec 28, 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