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510(k) Data Aggregation
K Number
K073705Device Name
MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE
Manufacturer
Date Cleared
2008-03-24
(84 days)
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG QIAOPAI GROUP CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Scalp Vein Set: intended to be used for insertion into the patient's vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood.
Sterile hypodermic needles for single use: intended for use to inject or withdraw fluids from the body.
Device Description
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