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510(k) Data Aggregation
K Number
K050134Device Name
ICC INSULIN SAFEPRO SAFETY SYRINGE
Manufacturer
Date Cleared
2005-04-05
(74 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
FORMOSA MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The primary indicated use for the 1cc Insulin SafePro* Safety Syringe is for aspirating and injecting insulin fluid.
The secondary indicated use for the 1cc Insulin SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
Device Description
The 1cc Insulin SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries. Other than scale graduation for use with U-100 strength insulin, the 1cc Insulin SafePro* Safety Syringe is essentially identical to the legally marketed 1cc SafePro* Safety Syringe in design and materials of construction.
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K Number
K031830Device Name
SAFEPRO PLUS SAFETY SYRINGE
Manufacturer
Date Cleared
2003-08-05
(53 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
FORMOSA MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The primary indicated use for the SafePro* Plus Safety Syringe is for general purpose use in aspirating and injecting fluid.
The secondary indicated use for the SafePro* Plus Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
Device Description
The SafePro* Plus Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries.
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K Number
K022063Device Name
SAFEPRO SAFETY SYRINGE
Manufacturer
Date Cleared
2002-08-29
(65 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
FORMOSA MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The primary indicated use for the 1cc SafePro* Safety Syringe is for general purpose use in aspirating and injecting fluid. The secondary indicated use for the 1cc SafePro * Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
Device Description
The 1cc SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature which may aid in the reduction of the risk of accidental needlestick injuries.
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