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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Nasal
510(k) Number K864932
Device Name 'EXMOOR' CAWOOD NASAL SPLINTS
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 Number874.5800
Classification Product Code
EPP  
Date Received12/16/1986
Decision Date 03/04/1987
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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