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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 K192710
Device Name The Simple Locking Intramedullary (Slim) System
Applicant
Pega Medical Inc.
111 Autoroute Chomeday
Laval,  CA H7w55j8
Applicant Contact Ariel R. Dujovne
Correspondent
Pega Medical Inc.
111 Autoroute Chomeday
Laval,  CA H7w55j8
Correspondent Contact Ariel R. Dujovne
Regulation Number888.3020
Classification Product Code
HSB  
Date Received09/27/2019
Decision Date 06/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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