ENEMA BAG SET

Enema Kit

ORION LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Enema Bag Set.

Pre-market Notification Details

Device IDK901182
510k NumberK901182
Device Name:ENEMA BAG SET
ClassificationEnema Kit
Applicant ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling,  IL  60090
ContactJohn L Laemmar
CorrespondentJohn L Laemmar
ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling,  IL  60090
Product CodeFCE  
CFR Regulation Number876.5210 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-13
Decision Date1990-06-28

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