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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K230235
Device Name Medline Luer Lock Syringes
Applicant
Medline Industries, LP
Three L akes Drive
Northfield,  IL  60093
Applicant Contact Kelsey Closen
Correspondent
Medline Industries, LP
Three L akes Drive
Northfield,  IL  60093
Correspondent Contact Kelsey Closen
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/27/2023
Decision Date 02/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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