FRASTEC CONFORMANT DRESSING, VARIOUS SIZES
Device Facts
| Record ID | K885325 |
|---|---|
| Device Name | FRASTEC CONFORMANT DRESSING, VARIOUS SIZES |
| Applicant | Frastec Wound Care Products, Inc. |
| Product Code | NAD · General, Plastic Surgery |
| Decision Date | Apr 17, 1989 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4020 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
