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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 K182146
Device Name Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
Applicant
Sol-Millennium Medical, Inc.
1735 N. Brown Rd., Suite 120
Lawrenceville,  GA  30043
Applicant Contact James Barley
Correspondent
Sol-Millennium Medical, Inc.
1735 N. Brown Rd., Suite 120
Lawrenceville,  GA  30043
Correspondent Contact James Barley
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/08/2018
Decision Date 12/03/2018
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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