The following data is part of a premarket notification filed by Exciton Technologies Inc. with the FDA for Exsalt Sd7 Wound Dressing.
| Device ID | K083870 |
| 510k Number | K083870 |
| Device Name: | EXSALT SD7 WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | EXCITON TECHNOLOGIES INC. 6605 HRONTARIO STREET Mississauga, Ontario, CA L5t O3a |
| Contact | Sandra Reis |
| Correspondent | Sandra Reis EXCITON TECHNOLOGIES INC. 6605 HRONTARIO STREET Mississauga, Ontario, CA L5t O3a |
| 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 | 2008-12-29 |
| Decision Date | 2009-07-30 |
| Summary: | summary |