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510(k) Data Aggregation
K Number
K050131Device Name
INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
Manufacturer
M.K. MEDITECH CO. LTD.
Date Cleared
2005-04-05
(74 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
M.K. MEDITECH CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe intended for subcutaneous injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Device Description
The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse. It is a sterile, single-use, with a pre-attached single lumen hypodermic needle. Syringe volumes include 1 mL, 0.5 mL, and 0.3 mL. Needles range in size from 25G to 29G, with lengths of 3/8 inch to 1/2 inches. The InsoSAFE™ is provided individually wrapped, in shelf boxes of 100 units.
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K Number
K034031Device Name
10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
Manufacturer
M.K. MEDITECH CO. LTD.
Date Cleared
2004-01-21
(23 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
M.K. MEDITECH CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bak'Snap DuoProSS™ Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringc reuse.
Device Description
The 10 mL Bak'Snap DuoProSS™ Retractable Safety Syringe is a sterile, single-use, disposable and non-rcusable, manual, retractable safety syringe provided with or without needle. The modifications to the cleared product are the addition of a brand name, a change in syringe volume, and a change in a single syringe material.
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K Number
K031594Device Name
BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY
Manufacturer
M.K. MEDITECH CO. LTD.
Date Cleared
2003-06-06
(16 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
M.K. MEDITECH CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSS™) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Device Description
The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSSTM) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe provided with permanently attached needle. The Safety Tray Safety Allergy Syringe Tray consists of 25 Bak'Snap syringes within a single sterile barrier.
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K Number
K022806Device Name
DUOPRO SAFETY SYRINGE (DUOPROSS)
Manufacturer
M.K. MEDITECH CO. LTD.
Date Cleared
2002-09-19
(27 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
M.K. MEDITECH CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DuoPro™ Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and nonreusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Device Description
The modified DuoPro™ Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, 3 mL or 5 mL retractable safety syringe, provided with or without needle in various product configurations.
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K Number
K020623Device Name
DUOPRO SAFETY SYRINGE (DUOPROSS)
Manufacturer
M.K. MEDITECH CO. LTD.
Date Cleared
2002-05-02
(65 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
M.K. MEDITECH CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Device Description
The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable 3 mL safety syringe, provided with or without needle in various product configurations.
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