510(k) DEN070002
DEN070002 is an FDA 510(k) premarket notification submitted by Quick-Med Technologies, Inc. for the device "QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING". The FDA issued a decision of De Novo Granted on February 25, 2009. The device falls under product code NYS (Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)), a Class II device regulated under 21 CFR 878.4015. Quick-Med Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 25, 2009
- Date Received
- May 10, 2007
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
- Device Class
- Class II
- Regulation Number
- 878.4015
- Review Panel
- SU
- Submission Type
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.