The following data is part of a premarket notification filed by Exciton Technologies Inc. with the FDA for Exsalt Sd7 Wound Dressing With Adhesive Backing.
| Device ID | K133775 |
| 510k Number | K133775 |
| Device Name: | EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING |
| Classification | Dressing, Wound, Drug |
| Applicant | EXCITON TECHNOLOGIES INC. SUITE 4000, 10230 JASPER AVE Edmonton, Alberta, CA T5z 3n5 |
| Contact | Melanie Ussyk |
| Correspondent | Melanie Ussyk EXCITON TECHNOLOGIES INC. SUITE 4000, 10230 JASPER AVE Edmonton, Alberta, CA T5z 3n5 |
| 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 | 2013-12-12 |
| Decision Date | 2014-03-26 |
| Summary: | summary |