← Product Code [NYS](/submissions/SU/subpart-e%E2%80%94surgical-devices/NYS) · DEN070002

# QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING (DEN070002)

_Quick-Med Technologies, Inc. · NYS · Feb 25, 2009 · General, Plastic Surgery · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NYS/DEN070002

## Device Facts

- **Applicant:** Quick-Med Technologies, Inc.
- **Product Code:** [NYS](/submissions/SU/subpart-e%E2%80%94surgical-devices/NYS.md)
- **Decision Date:** Feb 25, 2009
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 878.4015
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NYS/DEN070002](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NYS/DEN070002)

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