BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE

Device, Gas Generating

MARION LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK862123
510k NumberK862123
Device Name:BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
ClassificationDevice, Gas Generating
Applicant MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City,  MI  64134
ContactWilliam H Guinty,jr
CorrespondentWilliam H Guinty,jr
MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City,  MI  64134
Product CodeKZJ  
CFR Regulation Number866.2580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-03
Decision Date1986-06-16

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