BULB IRRIGATION TRAY

Tray, Irrigation, Sterile

ORION LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Bulb Irrigation Tray.

Pre-market Notification Details

Device IDK900736
510k NumberK900736
Device Name:BULB IRRIGATION TRAY
ClassificationTray, Irrigation, Sterile
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 CodeEYN  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-16
Decision Date1990-04-17

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