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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, Porous Uncemented
510(k) Number K921525
Device Name HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS
Applicant
Implant Technology, Inc.
10 W. Aylesbury Rd.
Timonium,  MD  21093
Applicant Contact SAM SON
Correspondent
Implant Technology, Inc.
10 W. Aylesbury Rd.
Timonium,  MD  21093
Correspondent Contact SAM SON
Regulation Number888.3358
Classification Product Code
LPH  
Date Received04/03/1992
Decision Date 01/11/1995
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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