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510(k) K231724

Device
Flush Syringe (Prefilled 0.9% normal saline solution)
Applicant
Spm Medicare Pvt. , Ltd.
510(k) number
K231724
Product code
NGT
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-09
Date received
2023-06-13
Regulation
880.5200
Classification name
Saline, Vascular Access Flush
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sanjay Kumar
Address
B-40, Phase Ii Gautam Budh Nagar IN 201305 201305

FDA Registration Numbers#

Source Documents#

510(k) summary PDF