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FDA 510(k)

GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER

K-Number: K030574 · 2003-08-21

ApplicantGlustitch, Inc.
Decision Date2003-08-21
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER is the device name listed in this FDA 510(k) record. The listed applicant is Glustitch, Inc.. It received FDA 510(k) clearance on 2003-08-21 under 510(k) number K030574. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER?

GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER is a medical device that received FDA 510(k) clearance on 2003-08-21. The listed applicant is Glustitch, Inc.. The 510(k) number is K030574.

When did GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER receive FDA 510(k) clearance?

GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER received FDA 510(k) clearance on 2003-08-21, under 510(k) number K030574.

Who is the listed applicant for GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER?

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

What is the FDA product code for GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER?

The FDA product code for GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER is KMF.

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 Glustitch, Inc. 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.

K150032GluStitch Twist Tissue AdhesiveK083752GLUSEAL 90, MODEL GLU9010K071484PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040K013446GLUSITE, MODEL GLU002

Related Devices (Code: KMF)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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