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510(k) K180893

IHM Technology Bandage by Protege Biomedical — Product Code QSY

K180893 is an FDA 510(k) premarket notification submitted by Protege Biomedical for the device "IHM Technology Bandage". The FDA issued a decision of Substantially Equivalent on Sep 19, 2018. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 19, 2018
Date Received
Apr 5, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

To temporarily control bleeding and cover external wounds.

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FDA data resources