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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 K213054
Device Name Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
Applicant
Medline Industries, Inc.
Three Lakes Drive
Northfield,  IL  60093
Applicant Contact Dinah Rincones
Correspondent
Medline Industries, Inc.
Three Lakes Drive
Northfield,  IL  60093
Correspondent Contact Dinah Rincones
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Codes
FMI   MEG  
Date Received09/22/2021
Decision Date 12/09/2022
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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