ARTIMICROBIAL REMOVAL DEVICE

Device, Antimicrobial Drug Removal

MARION LABORATORIES, INC.

The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Artimicrobial Removal Device.

Pre-market Notification Details

Device IDK830372
510k NumberK830372
Device Name:ARTIMICROBIAL REMOVAL DEVICE
ClassificationDevice, Antimicrobial Drug Removal
Applicant MARION LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLJF  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-04
Decision Date1983-04-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.