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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, Resurfacing
510(k) Number K883212
Device Name LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
Applicant
Implant Technology, Inc.
400 Plaza Dr.
Secaucus,  NJ  07094
Applicant Contact PETER J SCRANTON
Correspondent
Implant Technology, Inc.
400 Plaza Dr.
Secaucus,  NJ  07094
Correspondent Contact PETER J SCRANTON
Regulation Number888.3400
Classification Product Code
KXA  
Date Received07/29/1988
Decision Date 11/22/1988
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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