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FDA 510(k)

ENDOLYMPHATIC SAC TO MASTOID T-SHUNT

K-Number: K974224 · 1998-01-27

ApplicantExmoor Plastics , Ltd.
Decision Date1998-01-27
Product CodeESZ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENDOLYMPHATIC SAC TO MASTOID T-SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Exmoor Plastics , Ltd.. It received FDA 510(k) clearance on 1998-01-27 under 510(k) number K974224. 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 ENDOLYMPHATIC SAC TO MASTOID T-SHUNT?

ENDOLYMPHATIC SAC TO MASTOID T-SHUNT is a medical device that received FDA 510(k) clearance on 1998-01-27. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K974224.

When did ENDOLYMPHATIC SAC TO MASTOID T-SHUNT receive FDA 510(k) clearance?

ENDOLYMPHATIC SAC TO MASTOID T-SHUNT received FDA 510(k) clearance on 1998-01-27, under 510(k) number K974224.

Who is the listed applicant for ENDOLYMPHATIC SAC TO MASTOID T-SHUNT?

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

What is the FDA product code for ENDOLYMPHATIC SAC TO MASTOID T-SHUNT?

The FDA product code for ENDOLYMPHATIC SAC TO MASTOID T-SHUNT is ESZ.

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Other records listing Exmoor Plastics , Ltd. 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.

K093863EPIDRUMK990366EXMOOR SUCTION CLEARANCE KITK980828EXMOOR MYRINGOTOMY KITK981143DILKES LASER/SUCTION CANNULAEK972700EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)K981088MILLS COLUMELLA PROSTHESIS

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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.

K952227C-FLEX ENDOLYMPHATIC SHUNTTrebay Medical Corp.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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