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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Shunt, Endolymphatic
510(k) Number K974224
Device Name ENDOLYMPHATIC SAC TO MASTOID T-SHUNT
Applicant
Exmoor Plastics , Ltd.
Lisieux Way
Taunton,  GB TA1 2LB
Applicant Contact MARGARET BLACKMORE
Correspondent
Exmoor Plastics , Ltd.
Lisieux Way
Taunton,  GB TA1 2LB
Correspondent Contact MARGARET BLACKMORE
Regulation Number874.3820
Classification Product Code
ESZ  
Date Received11/10/1997
Decision Date 01/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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