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510(k) Data Aggregation
K Number
K152803Device Name
SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE
Manufacturer
Date Cleared
2016-07-12
(288 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
SUNG SHIM MEDICARE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SUNGSHIM® Sterile single use Insulin Syringe is hypodermic insulin syringe for subcutaneous injection of U-100 insulin. (Unit scale : U-100)
Device Description
SUNGSHIM® Sterile single use Insulin Syringe is a disposable, single use syringe which consists of a calibrated hollow barrel, plunger, gasket, cap and fixed needle is a fixed and the needle cap is intended to provide physical protection to the needle. The cap is color coded orange for U-100 insulin, same as equivalent insulin syringes. The SUNGSHIM Sterile single is available in 0.5ml/cc and 1ml/cc sizes in gauges 28g to 31g.
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