The following data is part of a premarket notification filed by Aroa Biosurgery with the FDA for Endoform Silver Dermal Template.
| Device ID | K172318 |
| 510k Number | K172318 |
| Device Name: | Endoform Silver Dermal Template |
| Classification | Dressing, Wound, Drug |
| Applicant | Aroa Biosurgery 2 Kingsford Smith Place Airport Oaks, NZ 2022 |
| Contact | Tina O'brien |
| Correspondent | Tina O'brien Aroa Biosurgery 2 Kingsford Smith Place Airport Oaks, NZ 2022 |
| 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 | 2017-08-01 |
| Decision Date | 2017-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09421905067348 | K172318 | 000 |
| 09421906017588 | K172318 | 000 |
| 09421906017533 | K172318 | 000 |
| 09421906017540 | K172318 | 000 |
| 09421906017557 | K172318 | 000 |
| 09421906017564 | K172318 | 000 |
| 09421906017571 | K172318 | 000 |
| 09421904065420 | K172318 | 000 |
| 09421904065598 | K172318 | 000 |
| 09421904065604 | K172318 | 000 |
| 09421904065611 | K172318 | 000 |
| 09421905067386 | K172318 | 000 |
| 09421905067379 | K172318 | 000 |
| 09421906017427 | K172318 | 000 |