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FDA 510(k)

ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING

K-Number: K974348 · 1998-02-13

ApplicantLaboratoires Urgo S.A.
Decision Date1998-02-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Laboratoires Urgo S.A.. It received FDA 510(k) clearance on 1998-02-13 under 510(k) number K974348. 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 ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING?

ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING is a medical device that received FDA 510(k) clearance on 1998-02-13. The listed applicant is Laboratoires Urgo S.A.. The 510(k) number is K974348.

When did ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING receive FDA 510(k) clearance?

ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING received FDA 510(k) clearance on 1998-02-13, under 510(k) number K974348.

Who is the listed applicant for ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING?

The FDA 510(k) record lists Laboratoires Urgo S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING?

The FDA product code for ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing Laboratoires Urgo S.A. 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.

K970518ALGOPLAQUE HYDROCOLLOID DRESSING

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

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

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