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510(k) Data Aggregation
K Number
K032848Device Name
MEDSAFE SYSTEM INSERTER
Manufacturer
Date Cleared
2004-04-12
(213 days)
Product Code
Regulation Number
880.6920Why did this record match?
Applicant Name (Manufacturer) :
MEDSOLVE TECHNOLOGIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Single-use non-sterile device intended to aid in the insertion of a commercially available syringe. The Safety feature prevents needle reuse.
Device Description
This device is used in conjunction with a commercially available syringe to aid in the insertion of the syringe needle. The device is constructed of thick walled rigid polycarbonate injection molded components, and a spring, that are permanently assembled within a housing. The devices are provided bulk non-sterile to the user. The user fills a standard syringe and places it in the device. The user positions the device against the injection site. The safety feature is unlocked by rotating the moving carrier. The insertion spring is activated by pressing the device against the skin at the injection site. This spring advances the syringe such that the needle penetrates the skin. The user dispenses the medication by depressing the syringe plunger. Two 'legs' snap over the plunger at the end of the injection stroke to capture the syringe plunger. The device is disposed of in appropriate sharps containers according to local, state, and Federal regulations.
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