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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 K883667
Device Name DONALDSON VENTILATION TUBES PT. # AG/S9
Applicant
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET,  GB TA1 2LB
Applicant Contact BRIAN G EAST
Correspondent
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET,  GB TA1 2LB
Correspondent Contact BRIAN G EAST
Regulation Number874.3880
Classification Product Code
ETD  
Date Received08/26/1988
Decision Date 11/14/1988
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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