The following data is part of a premarket notification filed by Exciton Technologies, Inc. with the FDA for Kerracontact Ag Perf Advanced Perforated Silver Wound Dressing.
| Device ID | K182680 |
| 510k Number | K182680 |
| Device Name: | KerraContact Ag Perf Advanced Perforated Silver Wound Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Exciton Technologies, Inc. 10230 Jasper Avenue, Suite 4147 Edmonton, CA T5j 4p6 |
| Contact | Melanie Ussyk |
| Correspondent | Melanie Ussyk Exciton Technologies, Inc. 10230 Jasper Avenue, Suite 4147 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 | 2018-09-26 |
| Decision Date | 2018-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540127000505 | K182680 | 000 |
| 07540127000444 | K182680 | 000 |
| 07540127000413 | K182680 | 000 |
| 07540127000383 | K182680 | 000 |
| 07540127000352 | K182680 | 000 |