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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Dead Space Piston Syringe
510(k) Number K252814
Device Name Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe
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 Number880.5860
Classification Product Code
QNQ  
Subsequent Product Code
MEG  
Date Received09/04/2025
Decision Date 02/19/2026
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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