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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 K252033
Device Name Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
Applicant
Cmt Health Pte., Ltd.
150 Beach Rd., #28-05, Gateway W.
Singapore,  SG 189720
Applicant Contact Monica Ma
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/30/2025
Decision Date 07/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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