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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 K111232
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 Received05/02/2011
Decision Date 01/26/2012
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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