The following data is part of a premarket notification filed by Exciton Technologies Inc. with the FDA for Kerracel Ag Gelling Fiber Silver Dressing.
| Device ID | K162508 |
| 510k Number | K162508 |
| Device Name: | KerraCel Ag Gelling Fiber Silver Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Exciton Technologies Inc. 10230 Jasper Ave., Suite 4147 Edmonton, CA T5j 4p6 |
| Contact | Melanie Ussyk |
| Correspondent | Melanie Ussyk Exciton Technologies Inc. 10230 Jasper Ave., Suite 4147 Edmonton, CA T5j 4p6 |
| 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 | 2016-09-08 |
| Decision Date | 2017-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060077233997 | K162508 | 000 |
| 07540127000208 | K162508 | 000 |
| 07540127000239 | K162508 | 000 |
| 07540127000260 | K162508 | 000 |
| 07540127000291 | K162508 | 000 |
| 07540127000321 | K162508 | 000 |
| 05060077233522 | K162508 | 000 |
| 05060077233553 | K162508 | 000 |
| 05060077233584 | K162508 | 000 |
| 05060077233614 | K162508 | 000 |
| 05060077233676 | K162508 | 000 |
| 05060077233706 | K162508 | 000 |
| 07540127000178 | K162508 | 000 |