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Found 3 results
510(k) Data Aggregation
K Number
K972839Device Name
PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET
Manufacturer
GLOBE ENT., INC.
Date Cleared
1997-12-17
(138 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
GLOBE ENT., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner.
Device Description
PROTOS® 100ml Burette Infusion Set/PROTOS® 150ml Burette Infusion
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K Number
K972854Device Name
PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY
Manufacturer
GLOBE ENT., INC.
Date Cleared
1997-12-17
(138 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
GLOBE ENT., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner.
Device Description
PROTOS® I.V. Administration Set (15 Drops/ML) and (60 Drops/ML)
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K Number
K972843Device Name
PROTOS BLOOD TRANSFUSION SET
Manufacturer
GLOBE ENT., INC.
Date Cleared
1997-12-16
(137 days)
Product Code
BRZ
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
GLOBE ENT., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the delivery of blood or blood related solutions by or on the order of a physician or other licensed practitioner.
Device Description
Not Found
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