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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K261372
Device Name Profoject™ LOR 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 Number868.5140
Classification Product Code
CAZ  
Date Received04/27/2026
Decision Date 09/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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