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FDA 510(k)

DERMAGRAN WOUND DRESSING CLEANER W/ZINC

K-Number: K954743 · 1995-11-02

ApplicantDerma Sciences, Inc.
Decision Date1995-11-02
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

DERMAGRAN WOUND DRESSING CLEANER W/ZINC is the device name listed in this FDA 510(k) record. The listed applicant is Derma Sciences, Inc.. It received FDA 510(k) clearance on 1995-11-02 under 510(k) number K954743. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMAGRAN WOUND DRESSING CLEANER W/ZINC?

DERMAGRAN WOUND DRESSING CLEANER W/ZINC is a medical device that received FDA 510(k) clearance on 1995-11-02. The listed applicant is Derma Sciences, Inc.. The 510(k) number is K954743.

When did DERMAGRAN WOUND DRESSING CLEANER W/ZINC receive FDA 510(k) clearance?

DERMAGRAN WOUND DRESSING CLEANER W/ZINC received FDA 510(k) clearance on 1995-11-02, under 510(k) number K954743.

Who is the listed applicant for DERMAGRAN WOUND DRESSING CLEANER W/ZINC?

The FDA 510(k) record lists Derma Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMAGRAN WOUND DRESSING CLEANER W/ZINC?

The FDA product code for DERMAGRAN WOUND DRESSING CLEANER W/ZINC is FRO. This falls under the Anesthesiology category.

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Other records listing Derma Sciences, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110546MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEYK101793MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEYK081584DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEYK080315DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEYK072956MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEYK970660DERMAGRAN WOUND MANAGEMENT SYSTEM

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Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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