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FDA 510(k)

ALGODERM ALGINATE WOUND DRESSING

K-Number: K905314 · 1991-02-19

ApplicantLes Laboratorires Brothier, S.A.
Decision Date1991-02-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ALGODERM ALGINATE WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Les Laboratorires Brothier, S.A.. It received FDA 510(k) clearance on 1991-02-19 under 510(k) number K905314. 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 ALGODERM ALGINATE WOUND DRESSING?

ALGODERM ALGINATE WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1991-02-19. The listed applicant is Les Laboratorires Brothier, S.A.. The 510(k) number is K905314.

When did ALGODERM ALGINATE WOUND DRESSING receive FDA 510(k) clearance?

ALGODERM ALGINATE WOUND DRESSING received FDA 510(k) clearance on 1991-02-19, under 510(k) number K905314.

Who is the listed applicant for ALGODERM ALGINATE WOUND DRESSING?

The FDA 510(k) record lists Les Laboratorires Brothier, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALGODERM ALGINATE WOUND DRESSING?

The FDA product code for ALGODERM ALGINATE WOUND DRESSING is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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.

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Other records listing Les Laboratorires Brothier, 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.

K041446NASALCEASEK984069ENTAXIS NASAL PACKINGK922540WOUND DRESSINGK893123ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES

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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