The following data is part of a premarket notification filed by Westaim Biomedical, Inc. with the FDA for Acticoat 7 Dressing.
| Device ID | K001519 |
| 510k Number | K001519 |
| Device Name: | ACTICOAT 7 DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | WESTAIM BIOMEDICAL, INC. ONE HAMPTON RD. SUITE 302 Exeter, NH 03833 |
| Contact | Steve Chartier |
| Correspondent | Steve Chartier WESTAIM BIOMEDICAL, INC. ONE HAMPTON RD. SUITE 302 Exeter, NH 03833 |
| 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 | 2000-05-16 |
| Decision Date | 2000-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00040565122038 | K001519 | 000 |
| 00040565121376 | K001519 | 000 |
| 00040565121451 | K001519 | 000 |