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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 K160545
Device Name GAP ENDO-EXO MEDULLARY SYSTEM
Applicant
PEGA MEDICAL INC.
1111 AUTOROUTE CHOMEDEY
LAVAL,  CA H7W 5J8
Applicant Contact Ariel R. Dujovne
Correspondent
PEGA MEDICAL INC.
1111 AUTOROUTE CHOMEDEY
LAVAL,  CA H7W 5J8
Correspondent Contact Ariel R. Dujovne
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/26/2016
Decision Date 11/23/2016
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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