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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Enteral
510(k) Number K253558
Device Name Luminoah FLOW™ Enteral Nutrition System
Applicant
Luminoah
1 Morton Dr.
Suite 100
Charlottesville,  VA  22903
Applicant Contact Neal Piper
Correspondent
Luminoah
1 Morton Dr.
Suite 100
Charlottesville,  VA  22903
Correspondent Contact Edgar (Rawley) Rearick
Regulation Number880.5725
Classification Product Code
LZH  
Date Received11/17/2025
Decision Date 04/20/2026
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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