510(k) K252677

Device
Polyshield Safety IV Catheters
Applicant
Poly Medicure Limited
510(k) number
K252677
Product code
FOZ
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-05
Date received
2025-08-25
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
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
S. S. Rawat
Address
Plot # 115-117, Sector-59 Hsiidc Industrial Area, Ballabhgarh Faridabad IN 121004 121004

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FOZ

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