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510(k) Data Aggregation
K Number
K211482Device Name
Disposable Syringe with Needle
Manufacturer
Date Cleared
2022-01-24
(257 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Shandong Qinkai Medical Industry Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sterile single-use syringe with needle is intended to inject fluids into or withdraw fluids from the body.
Device Description
The subject device is for single use only, which is comprised of syringes and needles with various specifications. The syringe consists of barrel, plunger, piston, and the needle consist of needle hub, needle cap. The proposed devices shall be operated manually, and are not intended for use with syringe pumps. The proposed devices are available in a variety combination of needle size and syringe volume.
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