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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 K211292
Device Name Fassier-Duval Telescopic IM System
Applicant
Pega Medical Inc.
1111 Autoroute Chomedey
Laval,  CA H7W 5J8
Applicant Contact Enrique Garcia
Correspondent
Pega Medical Inc.
1111 Autoroute Chomedey
Laval,  CA H7W 5J8
Correspondent Contact Enrique Garcia
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/28/2021
Decision Date 05/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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