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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteral Syringes With Enteral Specific Connectors
510(k) Number K253268
Device Name Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
Applicant
CMT Health PTE., Ltd.
150 Beach Rd., #28-05, Gateway W.
Singapore,  SG 189720
Applicant Contact Monica Ma
Correspondent
CMT Health PTE., Ltd.
150 Beach Rd., #28-05, Gateway W.
Singapore,  SG 189720
Correspondent Contact Monica Ma
Regulation Number876.5980
Classification Product Code
PNR  
Subsequent Product Code
PIO  
Date Received09/29/2025
Decision Date 04/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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