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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 -2584
Applicant Contact MARGARET CROWE
Correspondent
HOWMEDICA OSTEONICS CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070 -2584
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
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