The following data is part of a premarket notification filed by Exciton Technologies Inc. with the FDA for Exsalt Sd7 Wound Dressing.
| Device ID | K103067 |
| 510k Number | K103067 |
| Device Name: | EXSALT SD7 WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | EXCITON TECHNOLOGIES INC. SUITE 4232, 10230 JASPER AVE Edmonton, CA T5j 4p6 |
| Contact | Rod Precht |
| Correspondent | Rod Precht EXCITON TECHNOLOGIES INC. SUITE 4232, 10230 JASPER AVE 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 | 2010-10-18 |
| Decision Date | 2011-05-20 |
| Summary: | summary |