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510(k) Data Aggregation
K Number
K071567Device Name
AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE
Manufacturer
Date Cleared
2007-09-14
(99 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
AUTOSAFE-REFELX INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AutoSafe Safety Needles are indicated to be used to inject fluids into or withdraw fluid from the body. They are compatible for use with standard luer slip and luer lock syringes. Additionally, the passive needle safety shield is designed to help prevent needlestick injuries by shielding the needle before use, between steps and after use.
Device Description
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