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510(k) Data Aggregation
K Number
K012726Device Name
PROSAFE SAFETY SYRINGE
Manufacturer
Date Cleared
2001-10-18
(64 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
HOU-SE MEDICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A properly placed syringe provides access to a vein or tissue for fluid sampling or infusion. The safety syringe is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a needle retraction system which is activated after the infusion procedure is completed.
Device Description
The SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries.
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