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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K211612
Device Name Medline UNITE REFLEX Dynamic Discs
Applicant
Medline Industries, Inc.
Three Lakes Dr.
Nortfield,  IL  60093
Applicant Contact Jennifer Mason
Correspondent
Medline Industries, Inc.
Three Lakes Dr.
Nortfield,  IL  60093
Correspondent Contact Jennifer Mason
Regulation Number888.3030
Classification Product Code
HTN  
Date Received05/26/2021
Decision Date 12/10/2021
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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