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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 K210268
Device Name LTJ Screws and Washer
Applicant
Azurmeds, Inc.
4809 N Ravenswood Ave. Suite 119
Chicago,  IL  60604
Applicant Contact Jean-Marie Berger
Correspondent
Azurmeds, Inc.
4809 N Ravenswood Ave. Suite 119
Chicago,  IL  60604
Correspondent Contact Jean-Marie Berger
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received02/01/2021
Decision Date 02/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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