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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K254123
Device Name Ecomed Disposable Administration Sets
Applicant
Ecomed Solutions, LLC
2910 Falling Waters Blvd.
Lindenhurst,  IL  60046
Applicant Contact David Yurek
Correspondent
Ecomed Solutions, LLC
2910 Falling Waters Blvd.
Lindenhurst,  IL  60046
Correspondent Contact David Yurek
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/19/2025
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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