The following data is part of a De Novo classification by Quick-med Technologies, Inc. with the FDA for Qmt Nimbus Antimicrobial Barrier Gauze Dressing.
| DeNovo ID | DEN070002 |
| Device Name: | QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING |
| Classification | Wound Dressing With Poly(diallyl Dimethyl Ammonium Chloride)(pdadmac) |
| Applicant | QUICK-MED TECHNOLOGIES, INC. 3427 Sw 42nd Way Gainesville, FL 32608 |
| Contact | Roy Carr |
| Product Code | NYS |
| CFR Regulation Number | 878.4015 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K060662 |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Post-NSE |
| Date Received | 2007-05-10 |
| Decision Date | 2009-02-25 |
| Reclassification Order: | Reclassification Order |