JELCO* DISC FILTER-0.2 MICRON

Filter, Infusion Line

JELCO LABORATORIES

The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Jelco* Disc Filter-0.2 Micron.

Pre-market Notification Details

Device IDK790471
510k NumberK790471
Device Name:JELCO* DISC FILTER-0.2 MICRON
ClassificationFilter, Infusion Line
Applicant JELCO LABORATORIES 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFPB  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-03-05
Decision Date1979-04-30

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