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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 K843461
Device Name BIOGLASS OSSICULAR RECONSTRUCTION PROSTH
Applicant
American Biomaterials Corp.
1000 Herrontown Rd.
Princeton,  NJ  08540
Applicant Contact TODD DERBIN
Correspondent
American Biomaterials Corp.
1000 Herrontown Rd.
Princeton,  NJ  08540
Correspondent Contact TODD DERBIN
Regulation Number874.3495
Classification Product Code
ETA  
Date Received09/05/1984
Decision Date 01/09/1985
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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