FILTER, INTRAVENOUS W/AUTO AIR VENT

Set, Administration, Intravascular

JELCO LABORATORIES

The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Filter, Intravenous W/auto Air Vent.

Pre-market Notification Details

Device IDK770589
510k NumberK770589
Device Name:FILTER, INTRAVENOUS W/AUTO AIR VENT
ClassificationSet, Administration, Intravascular
Applicant JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-03-28
Decision Date1977-05-23

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