MedCu Antibacterial Wound Dressings With Copper-Oxide (MedCu ABWDs)

Dressing, Wound, Drug

MedCu Technologies, Ltd.

The following data is part of a premarket notification filed by Medcu Technologies, Ltd. with the FDA for Medcu Antibacterial Wound Dressings With Copper-oxide (medcu Abwds).

Pre-market Notification Details

Device IDK180643
510k NumberK180643
Device Name:MedCu Antibacterial Wound Dressings With Copper-Oxide (MedCu ABWDs)
ClassificationDressing, Wound, Drug
Applicant MedCu Technologies, Ltd. 23 David Elazar St. Herzlia,  IL 4627703
ContactGadi Borkow
CorrespondentTali Hazan
Talmed Ltd. MP Upper Galilee Ramot Naftali,  IL 1383000
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2018-03-12
Decision Date2018-11-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290018406342 K180643 000
07290018406335 K180643 000
07290018406328 K180643 000
07290018406311 K180643 000
07290018406304 K180643 000
07290018406298 K180643 000
07290018406281 K180643 000

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