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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 K132681
Device Name SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
Applicant
Sol-Millennium Medical, Inc.
5415 Sugarloaf Pkwy., Suite 2203
Lawrenceville,  GA  30043
Applicant Contact JIM BARLEY
Correspondent
Sol-Millennium Medical, Inc.
5415 Sugarloaf Pkwy., Suite 2203
Lawrenceville,  GA  30043
Correspondent Contact JIM BARLEY
Regulation Number880.5860
Classification Product Code
MEG  
Date Received08/28/2013
Decision Date 05/22/2014
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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