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FDA 510(k)

GLENROE ELASTIBITE STIMULATOR

K-Number: K924351 · 1994-01-06

ApplicantGlenroe Technologies
Decision Date1994-01-06
Product CodeKMY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLENROE ELASTIBITE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Glenroe Technologies. It received FDA 510(k) clearance on 1994-01-06 under 510(k) number K924351. The device is classified under product code KMY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLENROE ELASTIBITE STIMULATOR?

GLENROE ELASTIBITE STIMULATOR is a medical device that received FDA 510(k) clearance on 1994-01-06. The listed applicant is Glenroe Technologies. The 510(k) number is K924351.

When did GLENROE ELASTIBITE STIMULATOR receive FDA 510(k) clearance?

GLENROE ELASTIBITE STIMULATOR received FDA 510(k) clearance on 1994-01-06, under 510(k) number K924351.

Who is the listed applicant for GLENROE ELASTIBITE STIMULATOR?

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 ELASTIBITE STIMULATOR?

The FDA product code for GLENROE ELASTIBITE STIMULATOR is KMY.

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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.

K980053GLENROE CHAINK945535GLENROE ORTHO-SILK932920GLENROE PLASTIC BRACKETK924140TUFF TIESK924139GLENROE ORTHO SEPSK924211EJECTOR

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Related Devices (Code: KMY)

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.

K931615NITE-GUIDEORTHO-TAIN, Inc.K942667DENT-O-CRYL ORTHODONTIC ACRYLICDentauraum, Inc.K925064RELAX-O-GUARDAquatemp Service Co., Inc.K924975THE ORTHOTRAINERMyofunctional Research Corp. Pty. , Ltd.K924974THE TMJ APPLIANCEMyofunctional Research Corp. Pty. , Ltd.K904128PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONERAmerican Orthodontics

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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