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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tympanostomy
510(k) Number K921923
Device Name TITANIUM VENTILATION TUBES
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 Number874.3880
Classification Product Code
ETD  
Date Received04/08/1992
Decision Date 02/12/1993
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
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