The following data is part of a premarket notification filed by Aroa Biosurgery Ltd. with the FDA for Myriad Particles.
| Device ID | K200502 |
| 510k Number | K200502 |
| Device Name: | Myriad Particles |
| Classification | Dressing, Wound, Collagen |
| Applicant | Aroa Biosurgery Ltd. 2 Kingsford Smith Place Airport Oaks, NZ 2022 |
| Contact | Tina O'brien |
| Correspondent | Tina O'brien Aroa Biosurgery Ltd. 2 Kingsford Smith Place Airport Oaks, NZ 2022 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-28 |
| Decision Date | 2021-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09421905067928 | K200502 | 000 |
| 09421906017915 | K200502 | 000 |
| 09421906017922 | K200502 | 000 |
| 09421906017939 | K200502 | 000 |
| 09421906017946 | K200502 | 000 |
| 09421906017953 | K200502 | 000 |
| 09421906017960 | K200502 | 000 |
| 09421906017977 | K200502 | 000 |
| 09421905067911 | K200502 | 000 |
| 09421906017908 | K200502 | 000 |