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).
Device ID | K180643 |
510k Number | K180643 |
Device Name: | MedCu Antibacterial Wound Dressings With Copper-Oxide (MedCu ABWDs) |
Classification | Dressing, Wound, Drug |
Applicant | MedCu Technologies, Ltd. 23 David Elazar St. Herzlia, IL 4627703 |
Contact | Gadi Borkow |
Correspondent | Tali Hazan Talmed Ltd. MP Upper Galilee Ramot Naftali, IL 1383000 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2018-03-12 |
Decision Date | 2018-11-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290018406342 | K180643 | 000 |
07290018406335 | K180643 | 000 |
07290018406328 | K180643 | 000 |
07290018406311 | K180643 | 000 |
07290018406304 | K180643 | 000 |
07290018406298 | K180643 | 000 |
07290018406281 | K180643 | 000 |