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 |
| 07290018406489 | K180643 | 000 |