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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 K222744
Device Name Sol-M Luer Lock Syringe
Applicant
Sol-Millennium Medical, Inc.
315 Shawnee N. Dr.
Suite 100
Suwanee,  GA  30024
Applicant Contact Ying Zhao
Correspondent
Sol-Millennium Medical, Inc.
315 Shawnee N. Dr.
Suite 100
Suwanee,  GA  30024
Correspondent Contact Ying Zhao
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/12/2022
Decision Date 10/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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