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510(k) Data Aggregation
K Number
K023108Device Name
STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE
Manufacturer
ATLANTIC PRODUCTS, INC.
Date Cleared
2002-12-03
(76 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ATLANTIC PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STERIPACK Sterile Disposable Syringe is intended to be used for injecting fluids into, or withdraw fluids from, the body. The STERIPACK Sterile Disposable Insulin Syringe is intended to be used for the subcutaneous injection of insulin.
Device Description
The STERIPACK Sterile Disposable Syringe, with or without a hypodermic needle, is a sterile, single use, piston syringe, designed for manual use. The STERIPACK Sterile Disposable Syringe is available in 3, 5, 10 and 50 ml volume sizes with luer lock, slip tip, and eccentric configurations.
The STERIPACK Sterile Disposable Insulin Syringe with permanently affixed hypodermic needle, is a sterile, single use, insulin syringe, designed for manual use. The STERIPACK Sterile Disposable Insulin Syringe is available in 0.5 and 1.0 ml volume sizes, color coded with markings for delivery of 100 units of insulin/ml (U-100).
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