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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 K872112
Device Name XOMED PLATINUM WIRE TEFLON PISTION
Applicant
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216 -0980
Applicant Contact GORDON PETERS
Correspondent
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216 -0980
Correspondent Contact GORDON PETERS
Regulation Number874.3450
Classification Product Code
ETB  
Date Received06/01/1987
Decision Date 07/02/1987
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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