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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K893006
Device Name EXMOOR BITE BUFFER
Applicant
Exmoor Plastics , Ltd.
Lisieux Way
Taunton,  GB TA1 2LB
Applicant Contact BRIAN EAST
Correspondent
Exmoor Plastics , Ltd.
Lisieux Way
Taunton,  GB TA1 2LB
Correspondent Contact BRIAN EAST
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received04/24/1989
Decision Date 03/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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