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FDA 510(k)

UNIGLACTIN

K-Number: K072645 · 2007-11-07

ApplicantUnited Medical Industries Co. , Ltd.
Decision Date2007-11-07
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNIGLACTIN 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 2007-11-07 under 510(k) number K072645. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIGLACTIN?

UNIGLACTIN is a medical device that received FDA 510(k) clearance on 2007-11-07. The listed applicant is United Medical Industries Co. , Ltd.. The 510(k) number is K072645.

When did UNIGLACTIN receive FDA 510(k) clearance?

UNIGLACTIN received FDA 510(k) clearance on 2007-11-07, under 510(k) number K072645.

Who is the listed applicant for UNIGLACTIN?

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 UNIGLACTIN?

The FDA product code for UNIGLACTIN is GAM.

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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.

K072646UNICAPRONEK072644UNICRYL QUICKK042287UNIPLAIN & UNICHROMK042288UNICRYLK042285UNICRYL MK042284UNIMIDE

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Related Devices (Code: GAM)

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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