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FDA 510(k)

REPLICARE

K-Number: K880299 · 1988-02-26

ApplicantUnited Medical
Decision Date1988-02-26
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

REPLICARE is the device name listed in this FDA 510(k) record. The listed applicant is United Medical. It received FDA 510(k) clearance on 1988-02-26 under 510(k) number K880299. 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 REPLICARE?

REPLICARE is a medical device that received FDA 510(k) clearance on 1988-02-26. The listed applicant is United Medical. The 510(k) number is K880299.

When did REPLICARE receive FDA 510(k) clearance?

REPLICARE received FDA 510(k) clearance on 1988-02-26, under 510(k) number K880299.

Who is the listed applicant for REPLICARE?

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

What is the FDA product code for REPLICARE?

The FDA product code for REPLICARE 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 United Medical 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.

K883849REPLICARE (ADDITIONAL CLAIMS)K863389UNITED WOUND COVERING, PACKAGE OF 5K802828LIXIVITRON

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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