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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 K023241
Device Name TELEGRAPH HUMERAL NAIL
Applicant
Fournitures Hospitalieres Industrie
6258 Shady Grove Rd. E.
Memphis,  TN  38120
Applicant Contact M. FRANK LEWIS
Correspondent
Fournitures Hospitalieres Industrie
6258 Shady Grove Rd. E.
Memphis,  TN  38120
Correspondent Contact M. FRANK LEWIS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received09/30/2002
Decision Date 12/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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