QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING

• K Number: DEN070002
• Device Name: QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
• Manufacturer: QUICK-MED TECHNOLOGIES, INC.
• Date Cleared: 2009-02-25 ( 657 days)
• Product Code: NYS
• Regulation Number: 878.4015

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.

(a)
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.(b)
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.

Summary

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