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510(k) Data Aggregation
K Number
K060389Device Name
CONFIDOSE IM AUTO-INJECTOR
Manufacturer
Date Cleared
2006-06-06
(112 days)
Product Code
Regulation Number
880.6920Why did this record match?
Applicant Name (Manufacturer) :
PHARMA-PEN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ConfiDose™ IM auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and intramuscular injection of liquid drugs and biologics under the direction of a physician. The ConfiDose™ IM auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The ConfiDose™ IM auto-injector system is intended to mask needle insertion, injection and needle withdrawal from patient view.
Device Description
The ConfiDose™ IM auto-injector consists of a syringe cartridge with prefixed needle, power pack housing with spring loaded mechanism to insert a hypodermic needle into a patient to predetermined depth below the skin surface and a window tube with springloaded retraction mechanism. It is pressure actuated. Once activated, the device automatically performs all three steps of the injection process, needle insertion, drug injection and needle withdrawal. The ConfiDose™ IM auto-injector is individually packaged and ETO sterilized for single use.
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