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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 K920021
Device Name LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP
Applicant
IMPLANT TECHNOLOGY, INC.
400 PLAZA DR.
SECAUCUS,  NJ  07094
Applicant Contact HOWARD MANN
Correspondent
IMPLANT TECHNOLOGY, INC.
400 PLAZA DR.
SECAUCUS,  NJ  07094
Correspondent Contact HOWARD MANN
Regulation Number888.3350
Classification Product Code
JDI  
Date Received01/02/1992
Decision Date 03/25/1992
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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