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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, ent manual surgical
510(k) Number K892504
Device Name 'EXMOOR' SINGLE USE SUCTION TUBE
Applicant
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET,  GB TA1 2LB
Applicant Contact EAST, MCIM
Correspondent
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET,  GB TA1 2LB
Correspondent Contact EAST, MCIM
Regulation Number874.4420
Classification Product Code
LRC  
Date Received04/11/1989
Decision Date 06/22/1989
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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