The following data is part of a premarket notification filed by Westaim Biomedical, Inc. with the FDA for Modification To Acticoat Foam Dressing.
| Device ID | K010447 |
| 510k Number | K010447 |
| Device Name: | MODIFICATION TO ACTICOAT FOAM 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-13 |
| Decision Date | 2001-03-15 |