PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET

Set, Administration, Intravascular

GLOBE ENT., INC.

The following data is part of a premarket notification filed by Globe Ent., Inc. with the FDA for Protos 100ml Burette Infusion Set/ Protos 150ml Burette Infusion Set.

Pre-market Notification Details

Device IDK972839
510k NumberK972839
Device Name:PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant GLOBE ENT., INC. 4930 CAMPBELL RD. Houston,  TX  77041
ContactStephen Y Jan
CorrespondentStephen Y Jan
GLOBE ENT., INC. 4930 CAMPBELL RD. Houston,  TX  77041
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-01
Decision Date1997-12-17

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