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
| Device Type ID | 5791 |
| Device Name | Wound Dressing With Poly(diallyl Dimethyl Ammonium Chloride)(pdadmac) |
| Physical State | Wound Dressing |
| Technical Method | Topical Application |
| Target Area | Exuding Wounds And First And Second Degree Burns |
| Regulation Description | Wound Dressing With Poly (diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4015 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NYS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5791 |
| Device | Wound Dressing With Poly(diallyl Dimethyl Ammonium Chloride)(pdadmac) |
| Product Code | NYS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Wound Dressing With Poly (diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive. |
| CFR Regulation Number | 878.4015 [🔎] |