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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K223499
Device Name Three Way Stop Cock
Applicant
M/s Romsons International
Unit-II, 9, Noida Special Economic Zone, Noida Dadri Road,
Phase - II Noida, Gautam Buddha N
Noida,  IN 201305
Applicant Contact Kishore Narian Khanna
Correspondent
M/s Romsons International
Unit-II, 9, Noida Special Economic Zone, Noida Dadri Road,
Phase - II Noida, Gautam Buddha N
Noida,  IN 201305
Correspondent Contact Kishore Narian Khanna
Regulation Number880.5440
Classification Product Code
FMG  
Date Received11/21/2022
Decision Date 07/21/2023
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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