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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K131591
Device Name FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
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 Number888.3040
Classification Product Code
HWC  
Date Received05/31/2013
Decision Date 11/27/2013
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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