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510(k) Data Aggregation
K Number
K083193Device Name
REVAC AUTO RETRACTABLE SAFETY SYRINGE
Manufacturer
Date Cleared
2009-02-13
(107 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
REVOLUTIONS MEDICAL CORPORATION INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Reverse Vaccuum (RevVac) Safety Syringe, is a sterile, single use, disposable, autoretracting safety piston syringe which is intended for injection of fluid into the body, while reducing the risk of sharps injury and the potential for syringe reuse. The device is intended for use for subcutaneous and intramuscular use.
Device Description
The ReVac (Reverse Vacuum) Safety Syringe is a piston type hypodermic syringe with an automated needle retraction system. The device works like a typical syringe in that after removal of the cap, the user pulls back the syringe to feed liquid back into the barrel. Once the plunger is fully depressed, and the fluid inside is fully dispensed, a vacuum is created that is sufficient to force the retraction of the needle into the hollow chamber of the syringe. The needle is not visible and is fully inaccessible. The needle cannot be removed from the syringe without completely destroying the syringe.
The ReVac (Reverse Vacuum) Safety Syringe is a piston type hypodermic syringe with an automated needle retraction system. It is sterile, non-toxic, non-pyrogenic, retractable syringe designed to provide a safe reliable method for intramuscular and subcutaneous injection of drugs and or fluids while helping to provide protection from accidental needle sticks.
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