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510(k) Data Aggregation
K Number
K241856Device Name
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
Manufacturer
HLB LifeScience Co., Ltd.
Date Cleared
2024-12-23
(179 days)
Product Code
FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
HLB LifeScience Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Single use Syringe with or without Needle is intended to be used for medical purposes to inject fluid into or withdraw from body.
Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw from body. The filter operates when injecting the human body to remove foreign substances from the drug solutions.
Device Description
Single use Syringe with or without Needle consist of Syringe, Cap, Needle and Hub and Blister paper. Blister paper function to sustain sterilization of the product. The Cap function to protect the needle. This device is single use. This device is provided EO Sterilization, and the syringes of Luer Slip and Luer Lock.
These devices are injecting the medicine with syringes. Biocompatibility testing and performance testing has been completed to support the substantial equivalence of the device.
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