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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 K812669
Device Name SEATTLE II TOTAL HIP SYSTEM
Applicant
Hexcel Medical
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hexcel Medical
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3360
Classification Product Code
JDG  
Date Received09/21/1981
Decision Date 10/02/1981
Decision Substantially Equivalent (SESE)
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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