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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 K964243
Device Name HUMERUS WIRES
Applicant
Compagnie Financiere & Medicale (Cf&M)
13 Blvd. Victor Hugo
Bourge-En-Bresse,  FR 01000
Applicant Contact FRANK FERGUSON
Correspondent
Compagnie Financiere & Medicale (Cf&M)
13 Blvd. Victor Hugo
Bourge-En-Bresse,  FR 01000
Correspondent Contact FRANK FERGUSON
Regulation Number888.3020
Classification Product Code
HSB  
Date Received10/24/1996
Decision Date 12/05/1996
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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