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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 K020885
Device Name FASSIRE-DUVAL TELESCOPIC IM SYSTEM
Applicant
PEGA MEDICAL INC.
9260 VIAU BLVD.
ST-LEONARD (MONTREAL)
QUEBEC,  CA H1R 2V8
Applicant Contact ARIEL R DUJOVNE
Correspondent
PEGA MEDICAL INC.
9260 VIAU BLVD.
ST-LEONARD (MONTREAL)
QUEBEC,  CA H1R 2V8
Correspondent Contact ARIEL R DUJOVNE
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/18/2002
Decision Date 02/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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