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FDA 510(k)

GLENROE CHAIN

K-Number: K980053 · 1998-02-24

ApplicantGlenroe Technologies
Decision Date1998-02-24
Product CodeECI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLENROE CHAIN is the device name listed in this FDA 510(k) record. The listed applicant is Glenroe Technologies. It received FDA 510(k) clearance on 1998-02-24 under 510(k) number K980053. The device is classified under product code ECI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLENROE CHAIN?

GLENROE CHAIN is a medical device that received FDA 510(k) clearance on 1998-02-24. The listed applicant is Glenroe Technologies. The 510(k) number is K980053.

When did GLENROE CHAIN receive FDA 510(k) clearance?

GLENROE CHAIN received FDA 510(k) clearance on 1998-02-24, under 510(k) number K980053.

Who is the listed applicant for GLENROE CHAIN?

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

What is the FDA product code for GLENROE CHAIN?

The FDA product code for GLENROE CHAIN is ECI.

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Other records listing Glenroe Technologies 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.

K945535GLENROE ORTHO-SILK924351GLENROE ELASTIBITE STIMULATORK932920GLENROE PLASTIC BRACKETK924140TUFF TIESK924139GLENROE ORTHO SEPSK924211EJECTOR

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Related Devices (Code: ECI)

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.

K980864POWER COINS GLOW IN THE DARK LIGATURESOrtho Kinetics Corp.K973495GLENROE GLOW IN DARK ELASTOMERIC LIGATURESGlenroeK943419ORTHODONTIC ELASTOMERIC LAGATURE MODULEJon-Ko Products, Inc.K943418ORTHODONTIC ELASTOMERIC SEPARATOR MODULEJon-Ko Products, Inc.K943420ORTHODONTIC ELASTOMERIC CHAINJon-Ko Products, Inc.K943417ORTHODONTIC ELASTOMERIC TUBE/THREADJon-Ko Products, 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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