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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, ear suction
510(k) Number K973587
Device Name EXMOOR TYMPANOCENTESIS KIT (TK/1)
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 Number874.4420
Classification Product Code
JZF  
Date Received09/22/1997
Decision Date 01/23/1998
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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