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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name replacement, ossicular prosthesis, total
510(k) Number K981088
Device Name MILLS COLUMELLA PROSTHESIS
Applicant
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON,  GB TA1 2LB
Applicant Contact MARGARET BLACKEMORE
Correspondent
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON,  GB TA1 2LB
Correspondent Contact MARGARET BLACKEMORE
Regulation Number874.3495
Classification Product Code
ETA  
Date Received03/25/1998
Decision Date 06/05/1998
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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