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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K202732
Device Name SOL-CARE IV Bag Safety Connector
Applicant
Sol-Millennium Medical Group
315 Shawnee N. Dr.
Suite 100
Suwanee,  GA  30024
Applicant Contact Jim Barley
Correspondent
Sol-Millennium Medical Group
315 Shawnee N. Dr.
Suite 100
Suwanee,  GA  30024
Correspondent Contact Jim Barley
Regulation Number880.5440
Classification Product Code
LHI  
Subsequent Product Code
FPA  
Date Received09/18/2020
Decision Date 11/03/2021
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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