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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 K033510
Device Name MODIFICATION TO TELEGRAPH HUMERAL NAIL
Applicant
Fournitures Hospitalieres Industrie
Zi De Kernevez-6 Rue Nobel
Quimper Finistere,  FR 29000
Applicant Contact CHRISTINE QUENDEZ
Correspondent
Fournitures Hospitalieres Industrie
Zi De Kernevez-6 Rue Nobel
Quimper Finistere,  FR 29000
Correspondent Contact CHRISTINE QUENDEZ
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/06/2003
Decision Date 12/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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