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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K123684
Device Name SOL-CARE SAFETY NEEDLE
Applicant
Sol-Millennium Medical
5415 Sugarloaf Pkwy., Suite 2203
Lawrenceville,  GA  30043
Applicant Contact JIM BARLEY
Correspondent
Sol-Millennium Medical
5415 Sugarloaf Pkwy., Suite 2203
Lawrenceville,  GA  30043
Correspondent Contact JIM BARLEY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/30/2012
Decision Date 05/08/2013
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
Recalls CDRH Recalls
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