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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 K021662
Device Name MAGLY 6.5MM CANNULATED SCREWS
Applicant
Magly Orthopedics, LLC
14241 NE Woodinville-Duvall Rd.
#415
Woodinville,  WA  98072
Applicant Contact DAVE STINSON
Correspondent
Magly Orthopedics, LLC
14241 NE Woodinville-Duvall Rd.
#415
Woodinville,  WA  98072
Correspondent Contact DAVE STINSON
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/20/2002
Decision Date 08/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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