AIR VENT FILTER NEEDLE, 0.45

Filter, Infusion Line

JELCO LABORATORIES

The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Air Vent Filter Needle, 0.45.

Pre-market Notification Details

Device IDK771536
510k NumberK771536
Device Name:AIR VENT FILTER NEEDLE, 0.45
ClassificationFilter, Infusion Line
Applicant JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFPB  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-08-10
Decision Date1977-10-25

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