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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Nasopharyngeal
510(k) Number K883668
Device Name SUNDERLAND NASAL TUBE
Applicant
Exmoor Plastics , Ltd.
Lisieux Way
Taunton,  GB TA1 2LB
Applicant Contact BRIAN G EAST
Correspondent
Exmoor Plastics , Ltd.
Lisieux Way
Taunton,  GB TA1 2LB
Correspondent Contact BRIAN G EAST
Regulation Number868.5100
Classification Product Code
BTQ  
Date Received08/26/1988
Decision Date 11/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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