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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K844068
Device Name TROCHANTER CABLE GRIP SYSTEM
Applicant
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact STEVEN HOWARD
Correspondent
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact STEVEN HOWARD
Regulation Number888.3030
Classification Product Code
KTT  
Date Received10/18/1984
Decision Date 06/21/1985
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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