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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K993670
Device Name MODIFIED LONG LENGTH GAMMA NAIL
Applicant
Howmedica Osteonics Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact MARGARET CROWE
Correspondent
Howmedica Osteonics Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact MARGARET CROWE
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/01/1999
Decision Date 11/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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