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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Partial Ossicular Replacement
510(k) Number K893134
Device Name APACERAM OSSICULAR PROSTHESIS
Applicant
Asahi Optical Co. C/O Rosati Associates, P.C.
Attorney & Counselor At Law
31815 Southfield Rd. - #15
Birmingham,  MI  48009
Applicant Contact SAMUEL C URSU
Correspondent
Asahi Optical Co. C/O Rosati Associates, P.C.
Attorney & Counselor At Law
31815 Southfield Rd. - #15
Birmingham,  MI  48009
Correspondent Contact SAMUEL C URSU
Regulation Number874.3450
Classification Product Code
ETB  
Date Received04/25/1989
Decision Date 08/03/1989
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
Predetermined Change
Control Plan Authorized		 No
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