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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K162030
Device Name 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
Applicant
Sol-Millennium Medical, Inc.
1735 N. Brown Rd., Suite 120
Lawrenceville,  GA  30043
Applicant Contact JIM BARLEY
Correspondent
Sol-Millennium Medical, Inc.
1735 N. Brown Rd., Suite 120
Lawrenceville,  GA  30043
Correspondent Contact JIM BARLEY
Regulation Number880.5860
Classification Product Code
MEG  
Date Received07/22/2016
Decision Date 08/19/2016
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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