The following data is part of a premarket notification filed by Westaim Biomedical, Inc. with the FDA for Acticoat Primary Antimicrobial Dressing.
| Device ID | K992221 |
| 510k Number | K992221 |
| Device Name: | ACTICOAT PRIMARY ANTIMICROBIAL DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | WESTAIM BIOMEDICAL, INC. ONE HAMPTON RD. SUITE 302 Exeter, NH 03833 |
| Contact | Sally L Maher |
| Correspondent | Sally L Maher WESTAIM BIOMEDICAL, INC. ONE HAMPTON RD. SUITE 302 Exeter, NH 03833 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-01 |
| Decision Date | 2000-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00040565122014 | K992221 | 000 |
| 00040565121512 | K992221 | 000 |
| 00040565121475 | K992221 | 000 |
| 00040565121413 | K992221 | 000 |
| 00040565121352 | K992221 | 000 |
| 00040565122052 | K992221 | 000 |
| 00040565121536 | K992221 | 000 |