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510(k) Data Aggregation
K Number
K063631Device Name
POLYPERF / POLYPERF SAFE
Manufacturer
Date Cleared
2007-10-05
(303 days)
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
LABORATOIRES PEROUSE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
POLYPERF® / POLYPERF® Safe connecting lines are indicated for the administration into or withdrawal of fluids from implanted ports. POLYPERF® Safe is designed to help protect against exposure to blood caused by accidental needle stick injuries.
Device Description
POLYPERF®: Connection lines with Huber needle. Curved needle with luer lock and clamp with and without injection site.
POLYPERF® Safe: Safety Huber needle with connecting line. Prevention of ABE. Easy to perform positive Pressure.
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