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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 K885201
Device Name OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT
Applicant
Microbio-Medics, Inc.
Post Office Box 2487
Columbus,  MS  39704
Applicant Contact KEITH MCGEE
Correspondent
Microbio-Medics, Inc.
Post Office Box 2487
Columbus,  MS  39704
Correspondent Contact KEITH MCGEE
Regulation Number874.3495
Classification Product Code
ETA  
Date Received12/16/1988
Decision Date 04/19/1989
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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