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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 K002464
Device Name SMITH & NEPHEW OFF-CENTERED PORP
Applicant
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact ALICIA FARAGE
Correspondent
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact ALICIA FARAGE
Regulation Number874.3450
Classification Product Code
ETB  
Date Received08/10/2000
Decision Date 08/29/2000
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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