ENDOLYMPHATIC SAC TO MASTOID T-SHUNT— 510(k) K974224

Name: FDA 510(k) clearance K974224
Creator: U.S. Food and Drug Administration
Published: 1998-01-27

Substantially Equivalent

Exmoor Plastics , Ltd.

FDA 510(k) clearance K974224 for ENDOLYMPHATIC SAC TO MASTOID T-SHUNT, Substantially Equivalent on 1998-01-27. Applicant: Exmoor Plastics , Ltd.. Device class: 2.

Clearance details

Applicant: Exmoor Plastics , Ltd.
Product code: Code ESZ
Device class: Class 2
Regulation: 21 CFR 874.3820
Advisory panel: Ear, Nose, Throat
Date received: 1997-11-10
Decision date: 1998-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taunton, GB

Download summary PDF View on FDA.gov ↗

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