FDA.report

510(k) K223499

Device
Three Way Stop Cock
Applicant
M/S Romsons International
510(k) number
K223499
Product code
FMG
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-21
Date received
2022-11-21
Regulation
880.5440
Classification name
Stopcock, I.V. Set
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Kishore Narian Khanna
Address
Unit-Ii, 9, Noida Special Economic Zone, Noida Dadri Rd., Phase - Ii Noida, Gautam Buddha N Noida IN 201305 201305

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K082110DUAL SYRINGE HOLDERSurgin Surgical Instrumentation, Inc.2009-06-17
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K080077CLAVE STOPCOCKIcu Medical, Inc.2008-02-13
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