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510(k) K180643

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) by Medcu Technologies , Ltd. — Product Code FRO

K180643 is an FDA 510(k) premarket notification submitted by Medcu Technologies , Ltd. for the device "MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)". The FDA issued a decision of Substantially Equivalent on Nov 23, 2018. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 23, 2018
Date Received
Mar 12, 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