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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Inserter, Myringotomy Tube
510(k) Number K924901
Device Name DEANS DISPOSABLE T-TUBE INSERTER
Applicant
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET,  GB TA1 2LB
Applicant Contact BRIAN EAST
Correspondent
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET,  GB TA1 2LB
Correspondent Contact BRIAN EAST
Regulation Number874.4420
Classification Product Code
JYM  
Date Received09/09/1992
Decision Date 01/28/1993
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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