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FDA 510(k)

GLUSEAL 90, MODEL GLU9010

K-Number: K083752 · 2009-02-23

ApplicantGlustitch, Inc.
Decision Date2009-02-23
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLUSEAL 90, MODEL GLU9010 is the device name listed in this FDA 510(k) record. The listed applicant is Glustitch, Inc.. It received FDA 510(k) clearance on 2009-02-23 under 510(k) number K083752. 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 90, MODEL GLU9010?

GLUSEAL 90, MODEL GLU9010 is a medical device that received FDA 510(k) clearance on 2009-02-23. The listed applicant is Glustitch, Inc.. The 510(k) number is K083752.

When did GLUSEAL 90, MODEL GLU9010 receive FDA 510(k) clearance?

GLUSEAL 90, MODEL GLU9010 received FDA 510(k) clearance on 2009-02-23, under 510(k) number K083752.

Who is the listed applicant for GLUSEAL 90, MODEL GLU9010?

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 90, MODEL GLU9010?

The FDA product code for GLUSEAL 90, MODEL GLU9010 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 AdhesiveK071484PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040K030574GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSERK013446GLUSITE, 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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, 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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