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510(k) Data Aggregation
K Number
K971664Device Name
RAMY PISTON SYRINGE
Manufacturer
Date Cleared
1997-07-25
(80 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ALSHIFA MEDICAL SYRINGES MFG. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
General purpose single use piston syringe used to withdraw or inject first into the body. The device is sold as a sold as a sold as a sold and in a sold and is monther is sold device is sold device is not of The device is not intended for use with any specific drugs or biologics. It is sold as a prescription device with needle . attached and ready for use.
Device Description
RAMY Piston Syringe
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K Number
K972452Device Name
RAMY INTEGRATED NEEDLE SYRINGE
Manufacturer
Date Cleared
1997-07-24
(78 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ALSHIFA MEDICAL SYRINGES MFG. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Single use piston syringe used to inject fluids into the body. The device has an integrated attached needle and can be sold for prescription or non-prescription use. The tuberculin syringe is for prescription use and the insulin syringe can be sold for non-prescription use. The syringes are sold sterile and are also non-pyrogenic and non-toxic.
Device Description
RAMY PISTON SYRINGE
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