FDA.report

510(k) K230616

Device
Polyguard and Polyshield Safety IV Catheters
Applicant
Poly Medicure Limited
510(k) number
K230616
Product code
FOZ
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-05
Date received
2023-03-06
Regulation
880.5200
Classification name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Ramdas Sharma
Address
Plot # 115-116, Sector-59, Hsiidc Industrial Area Ballabgarh Faridabad IN 121004 121004

FDA Registration Numbers

Source Documents

510(k) summary PDF

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