SUCTION CATHETER, STERILE

Catheters, Suction, Tracheobronchial

ORION LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Suction Catheter, Sterile.

Pre-market Notification Details

Device IDK902814
510k NumberK902814
Device Name:SUCTION CATHETER, STERILE
ClassificationCatheters, Suction, Tracheobronchial
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 CodeBSY  
CFR Regulation Number868.6810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-28
Decision Date1990-08-17

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