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510(k) Data Aggregation
K Number
K953955Device Name
POWDERFREE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
Manufacturer
Date Cleared
1996-08-20
(371 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CODAN MEDLON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K953956Device Name
BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
Manufacturer
Date Cleared
1996-08-20
(371 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CODAN MEDLON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K953958Device Name
POWDERFREE BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
Manufacturer
Date Cleared
1996-08-20
(371 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CODAN MEDLON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K960921Device Name
CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE
Manufacturer
Date Cleared
1996-04-17
(42 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CODAN MEDLON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CODAN Spike is designed to be used to transfer medication from a vial to a syringe and from syringe to an IV set.
Device Description
The Codan Spike is a sterile, nonpyrogenic, multiple dose vial adapter for the preparation and withdrawal of medications and cytotoxic solutions. The Codan Spike contains a 0.20 pm pressure resistant hydrophobic filter that is pressure stable and hydrophobic.
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