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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 K041393
Device Name FASSIER-DUVAL TELSCOPIC IM SYSTEM
Applicant
Pega Medical, Inc.
9260 Boul. Viau
Montreal (Quebec),  CA H1R 2V8
Applicant Contact ARIEL R DUJOVNE
Correspondent
Pega Medical, Inc.
9260 Boul. Viau
Montreal (Quebec),  CA H1R 2V8
Correspondent Contact ARIEL R DUJOVNE
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/24/2004
Decision Date 08/17/2004
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
Recalls CDRH Recalls
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