NYS — Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac) Class II
FDA product code NYS covers "Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)", a Class II medical device regulated under 21 CFR 878.4015. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NYS
- Device Class
- Class II
- Regulation Number
- 878.4015
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
A wound dressing with poly (diallyl dimethyl ammonium chloride) (pdadmac) additive is a device that is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing. The device consists of a textile substrate and permanently bound pdadmac. The device acts as a physical barrier to outside contaminants and does not act on the surface or interior of the wound nor does it contain antimicrobial agents that act on the body.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN070002 | quick-med technologies | QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING | February 25, 2009 |