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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K251341
Device Name VITAL Tubing Sets for Hemodialysis
Applicant
Vital Healthcare Sdn. Bhd.
Pt 83718, Jalan Bestari 1a/Ku7
Taman Perindustrian Kapar Bestari
Kapar,  MY 42200
Applicant Contact Hui Zhen Ch'ng
Correspondent
Vital Healthcare Sdn. Bhd.
Pt 83718, Jalan Bestari 1a/Ku7
Taman Perindustrian Kapar Bestari
Kapar,  MY 42200
Correspondent Contact Hui Zhen Ch'ng
Regulation Number876.5820
Classification Product Code
FJK  
Date Received04/30/2025
Decision Date 01/16/2026
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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