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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 K963899
Device Name CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
Applicant
Exmoor Plastics , Ltd.
Lisieux Way
Taunton,  GB TA1 2LB
Applicant Contact BRIAN EAST
Correspondent
Exmoor Plastics , Ltd.
Lisieux Way
Taunton,  GB TA1 2LB
Correspondent Contact BRIAN EAST
Regulation Number874.3495
Classification Product Code
ETA  
Subsequent Product Code
ETB  
Date Received09/27/1996
Decision Date 08/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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