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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, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K922871
Device Name UNIFIT FEMORAL STEM
Applicant
Osteo Technology, Inc.
10 W. Aylesbury Rd.
Timonium,  MD  21093
Applicant Contact SAM SON
Correspondent
Osteo Technology, Inc.
10 W. Aylesbury Rd.
Timonium,  MD  21093
Correspondent Contact SAM SON
Regulation Number888.3350
Classification Product Code
JDI  
Date Received06/04/1992
Decision Date 02/12/1993
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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