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FDA 510(k)

UNITED WOUND COVERING, PACKAGE OF 5

K-Number: K863389 · 1986-11-17

ApplicantUnited Medical
Decision Date1986-11-17
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

UNITED WOUND COVERING, PACKAGE OF 5 is the device name listed in this FDA 510(k) record. The listed applicant is United Medical. It received FDA 510(k) clearance on 1986-11-17 under 510(k) number K863389. 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 UNITED WOUND COVERING, PACKAGE OF 5?

UNITED WOUND COVERING, PACKAGE OF 5 is a medical device that received FDA 510(k) clearance on 1986-11-17. The listed applicant is United Medical. The 510(k) number is K863389.

When did UNITED WOUND COVERING, PACKAGE OF 5 receive FDA 510(k) clearance?

UNITED WOUND COVERING, PACKAGE OF 5 received FDA 510(k) clearance on 1986-11-17, under 510(k) number K863389.

Who is the listed applicant for UNITED WOUND COVERING, PACKAGE OF 5?

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 UNITED WOUND COVERING, PACKAGE OF 5?

The FDA product code for UNITED WOUND COVERING, PACKAGE OF 5 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)K880299REPLICAREK802828LIXIVITRON

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.

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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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