The following data is part of a premarket notification filed by Vomaris Wound Care, Inc. with the FDA for Procellera Composite Antibacterial Wound Dressing.
| Device ID | K180533 |
| 510k Number | K180533 |
| Device Name: | Procellera Composite Antibacterial Wound Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Vomaris Wound Care, Inc. 1911 East Fifth Street Tempe, AZ 85281 |
| Contact | Charmaine Sutton |
| Correspondent | Charmaine Sutton Vomaris Wound Care, Inc. 1911 East Fifth Street Tempe, AZ 85281 |
| 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 | 2018-02-28 |
| Decision Date | 2018-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00894318002517 | K180533 | 000 |
| 00810198030181 | K180533 | 000 |
| 10888867351247 | K180533 | 000 |
| 10888867346243 | K180533 | 000 |
| 10888867346236 | K180533 | 000 |
| 00810198031546 | K180533 | 000 |
| 00810198031539 | K180533 | 000 |
| 00810198031522 | K180533 | 000 |
| 00888867458031 | K180533 | 000 |
| 00888867458024 | K180533 | 000 |
| 00810198030198 | K180533 | 000 |
| 00810198030280 | K180533 | 000 |
| 00894318002494 | K180533 | 000 |
| 00894318002487 | K180533 | 000 |
| 00894318002470 | K180533 | 000 |
| 00894318002463 | K180533 | 000 |
| 00894318002456 | K180533 | 000 |
| 00810198031140 | K180533 | 000 |
| 00810198030822 | K180533 | 000 |
| 00810198030419 | K180533 | 000 |
| 00810198030402 | K180533 | 000 |
| 00888867458017 | K180533 | 000 |