ENVISAN PASTE
Device Facts
| Record ID | K874553 |
|---|---|
| Device Name | ENVISAN PASTE |
| Applicant | Marion Laboratories, Inc. |
| Product Code | KOZ · General, Plastic Surgery |
| Decision Date | Dec 18, 1987 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4018 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic 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.
