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FDA 510(k)

C-FLEX ENDOLYMPHATIC SHUNT

K-Number: K952227 · 1995-06-16

ApplicantTrebay Medical Corp.
Decision Date1995-06-16
Product CodeESZ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

C-FLEX ENDOLYMPHATIC SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Trebay Medical Corp.. It received FDA 510(k) clearance on 1995-06-16 under 510(k) number K952227. The device is classified under product code ESZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-FLEX ENDOLYMPHATIC SHUNT?

C-FLEX ENDOLYMPHATIC SHUNT is a medical device that received FDA 510(k) clearance on 1995-06-16. The listed applicant is Trebay Medical Corp.. The 510(k) number is K952227.

When did C-FLEX ENDOLYMPHATIC SHUNT receive FDA 510(k) clearance?

C-FLEX ENDOLYMPHATIC SHUNT received FDA 510(k) clearance on 1995-06-16, under 510(k) number K952227.

Who is the listed applicant for C-FLEX ENDOLYMPHATIC SHUNT?

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

What is the FDA product code for C-FLEX ENDOLYMPHATIC SHUNT?

The FDA product code for C-FLEX ENDOLYMPHATIC SHUNT is ESZ.

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Other records listing Trebay Medical Corp. 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.

K955704TREBAY MICRODEBRIDER SYSTEMK955294SOF - ABRASION BURK955560TREBAY SCOPE IRRIGATED CLEARING SLEEVEK955447TYMPANOSTOMY TUBEK954912TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)K954795AT2 & DOYLE STYLE (C-FLEX) VENT TUBES

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Related Devices (Code: ESZ)

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.

K974224ENDOLYMPHATIC SAC TO MASTOID T-SHUNTExmoor Plastics , Ltd.K897049GIBSON ENDOLYMPHATIC SHUNTHood LaboratoriesK834094AUSTIN ENDOLYMPH DISPERSMENT SHUNTTreace Medical, 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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