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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 North Brown Road, Suite 120
Lawrenceville,  GA  30043
Applicant Contact James Barley
Correspondent
Sol-Millennium Medical, Inc.
1735 North Brown Road, 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
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