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FDA 510(k)

DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING

K-Number: K990891 · 1999-05-27

ApplicantDermaphylyx, Inc.
Decision Date1999-05-27
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Dermaphylyx, Inc.. It received FDA 510(k) clearance on 1999-05-27 under 510(k) number K990891. 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 for Some Indications.

Frequently Asked Questions

What is the DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING?

DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1999-05-27. The listed applicant is Dermaphylyx, Inc.. The 510(k) number is K990891.

When did DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING receive FDA 510(k) clearance?

DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING received FDA 510(k) clearance on 1999-05-27, under 510(k) number K990891.

Who is the listed applicant for DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING?

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

What is the FDA product code for DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING?

The FDA product code for DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Dermaphylyx, 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.

K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSK991920DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSINGK991933DERMAPHYLYX FOAM ISLAND DRESSINGK991609DERMAPHYLYX SUPER ABSORBENT FIBER DRESSINGK991608DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGK991061DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING

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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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