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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K260857
Device Name Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set
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 Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FPA  
Date Received03/16/2026
Decision Date 10/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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