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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 K163073
Device Name Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
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 Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FPA  
Date Received11/02/2016
Decision Date 05/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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