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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 K855017
Device Name LSF* TOTAL HIP SYSTEM
Applicant
Implant Technology, Inc.
400 Plz. Dr.
Secaucus,  NJ  07094
Applicant Contact LAINE MASHBURN
Correspondent
Implant Technology, Inc.
400 Plz. Dr.
Secaucus,  NJ  07094
Correspondent Contact LAINE MASHBURN
Regulation Number888.3350
Classification Product Code
JDI  
Date Received12/16/1985
Decision Date 06/11/1986
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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