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510(k) Data Aggregation
K Number
K113673Device Name
MYSAFETY SYRINGE
Manufacturer
Date Cleared
2012-08-03
(234 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
MEDICALCHAIN INTERNARTIONAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MySafety Syringe for Insulin is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe re-use and is a single use, disposable and retractable safety syringe which is intended for injection of insulin into the body.
Device Description
The MySafety Syringe for Insulin is a sterile, single-use, disposable, non-reusable, needle-retractable, piston syringe, provided with attached needle, which is intended for the injection of U-100 insulin into a diabetic patient, while minimizing the potential for accidental injury and preventing syringe reuse.
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