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510(k) Data Aggregation
K Number
K021197Device Name
SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16
Manufacturer
Date Cleared
2002-04-26
(10 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
HOSUK CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Insulin syringes are intended only for the injection of U-100 insulin.
Device Description
The sureone disposable insulin syringe is used for subcutaneous injection of U-100 insulin. This device is a sterile, single-use, disposable piston syringe with permanently affixed hypodermic single lumen needle. The sureone disposable insulin syringe consists of a syringe barrel, a plunger rod, and a hypodermic single lumen needle permanently bonded to the tip of the syringe with epoxy. The sureone disposable insulin syringes are available in 1.0cc (100 units), 0.5cc (50 units), and 0.3cc (30 units) syringe capacities with the following sizes of hypodermic single lumen needle: 28 GA x ½", 29 GA x ½", and 30 GA x 3/10". In addition, the 1.0cc and 0.5cc syringe capacities are available with a 31 GA x 5/16" needle.
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K Number
K002921Device Name
SUREONE INSULIN SYRINGE
Manufacturer
Date Cleared
2000-10-18
(29 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
HOSUK CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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