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510(k) Data Aggregation
K Number
K153553Device Name
SiO2 Coated syringe 3 ml
Manufacturer
Date Cleared
2016-05-17
(158 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
SiO2 Medical Products
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SiO2 Coated Syringe 3 mL is intended to be used to inject fluids into, or withdraw fluids from, the body.
Device Description
SiO2 Coated Syringe 3 mL is a plastic disposable standard 3 mL piston syringe without needle is made of a cyclic olefin polymer (COP) and coated internally with silica glass layers. The layer is deposited by plasma enhanced chemical vapor deposition (PECVD) process.
This is a standard 3 mL single use, disposable syringe without needle.
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