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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Wire, Surgical
510(k) Number K900926
Device Name TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)
Applicant
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact MARY C SPICER
Correspondent
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact MARY C SPICER
Regulation Number888.3030
Classification Product Code
LRN  
Date Received02/27/1990
Decision Date 04/23/1990
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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