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FDA 510(k)

UNIESTER C

K-Number: K042286 · 2004-12-01

ApplicantUnited Medical Industries Co. , Ltd.
Decision Date2004-12-01
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNIESTER C is the device name listed in this FDA 510(k) record. The listed applicant is United Medical Industries Co. , Ltd.. It received FDA 510(k) clearance on 2004-12-01 under 510(k) number K042286. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIESTER C?

UNIESTER C is a medical device that received FDA 510(k) clearance on 2004-12-01. The listed applicant is United Medical Industries Co. , Ltd.. The 510(k) number is K042286.

When did UNIESTER C receive FDA 510(k) clearance?

UNIESTER C received FDA 510(k) clearance on 2004-12-01, under 510(k) number K042286.

Who is the listed applicant for UNIESTER C?

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

What is the FDA product code for UNIESTER C?

The FDA product code for UNIESTER C is GAT.

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Other records listing United Medical Industries Co. , Ltd. 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.

K072646UNICAPRONEK072645UNIGLACTINK072644UNICRYL QUICKK042287UNIPLAIN & UNICHROMK042288UNICRYLK042285UNICRYL M

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Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, 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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