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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 K974008
Device Name PFLEIDERER'S INTRATYMPANIC CATHETER
Applicant
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET,  GB TA1 2LB
Applicant Contact MARGARET BLACKMORE
Correspondent
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET,  GB TA1 2LB
Correspondent Contact MARGARET BLACKMORE
Regulation Number874.3880
Classification Product Code
ETD  
Date Received10/17/1997
Decision Date 05/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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