Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4015](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4015) → NYS — Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

# NYS · Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

_General, Plastic Surgery · 21 CFR 878.4015 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NYS

## Overview

- **Product Code:** NYS
- **Device Name:** Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
- **Regulation:** [21 CFR 878.4015](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4015)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A wound dressing with pDADMAC additive is intended for use as a primary dressing for exuding wounds, 1st and 2d degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.

## Classification Rationale

Class II (special controls). The special control is: the FDA guidance document entitled “Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive.” See § 878.1(e) for availability of this guidance document.

## Special Controls

*Classification.* Class II (special controls). The special control is: the FDA guidance document entitled “Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive.” See § 878.1(e) for availability of this guidance document.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN070002](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NYS/DEN070002.md) | QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING | Quick-Med Technologies, Inc. | Feb 25, 2009 | DENG |

## Top Applicants

- Quick-Med Technologies, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NYS](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NYS)

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