The following data is part of a premarket notification filed by Exciton Technologies Inc. with the FDA for Exsalt T7 Wound Dressing.
| Device ID | K113564 |
| 510k Number | K113564 |
| Device Name: | EXSALT T7 WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | EXCITON TECHNOLOGIES INC. Suite 4000 10230 Jasper Avenue Edmonton, CA T5j 4p6 |
| Contact | Melanie Ussyk |
| Correspondent | Melanie Ussyk EXCITON TECHNOLOGIES INC. Suite 4000 10230 Jasper Avenue Edmonton, CA T5j 4p6 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-12-02 |
| Decision Date | 2011-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540127000147 | K113564 | 000 |
| 07540127000116 | K113564 | 000 |
| 07540127000086 | K113564 | 000 |
| 07540127000055 | K113564 | 000 |
| 07540127000024 | K113564 | 000 |
| 07540127000468 | K113564 | 000 |