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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 K252184
Device Name SOL-M Luer Lock Syringe with Exchangeable Needle Tray
Applicant
Sol-Millennium Medical, Inc.
311 S. Wacker Dr., Suite 4100
Chicago,  IL  60606
Applicant Contact Mike Xie
Correspondent
Sol-Millennium Medical, Inc.
311 S. Wacker Dr., Suite 4100
Chicago,  IL  60606
Correspondent Contact Mike Xie
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received07/11/2025
Decision Date 08/25/2026
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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