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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K260514
Device Name Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle
Applicant
CMT Health PTE., Ltd.
150 Beach Rooad, #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
FMF  
Subsequent Product Codes
FMI   MEG   QNQ  
Date Received02/17/2026
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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