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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Femoral Component, Cemented, Metal
510(k) Number K911595
Device Name INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact MICKI ROY
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact MICKI ROY
Regulation Number888.3360
Classification Product Code
JDG  
Date Received04/09/1991
Decision Date 07/12/1991
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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