The following data is part of a premarket notification filed by Exciton Technologies Inc. with the FDA for Exsalt Wound Dressing.
| Device ID | K100580 |
| 510k Number | K100580 |
| Device Name: | EXSALT WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | EXCITON TECHNOLOGIES INC. SUITE 4232, 10230 JASPER AVE Edmonton, Alberta, CA T5j 4p6 |
| Contact | John Simon |
| Correspondent | John Simon EXCITON TECHNOLOGIES INC. SUITE 4232, 10230 JASPER AVE Edmonton, Alberta, 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 | No |
| Date Received | 2010-03-02 |
| Decision Date | 2010-10-12 |
| Summary: | summary |