The following data is part of a premarket notification filed by Westaim Biomedical, Inc. with the FDA for Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-adhesive.
| Device ID | K983833 |
| 510k Number | K983833 |
| Device Name: | ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE |
| Classification | Bandage, Liquid |
| Applicant | WESTAIM BIOMEDICAL, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan WESTAIM BIOMEDICAL, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-30 |
| Decision Date | 1998-12-10 |
| Summary: | summary |