STERILE .9% SODIUM CHLORIDE FOR IRRATION

Catheter And Tip, Suction

ORION LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Sterile .9% Sodium Chloride For Irration.

Pre-market Notification Details

Device IDK943832
510k NumberK943832
Device Name:STERILE .9% SODIUM CHLORIDE FOR IRRATION
ClassificationCatheter And Tip, Suction
Applicant ORION LIFE SYSTEMS, INC. P.O. BOX 2308 Palm Harbor,  FL  34682 -2308
ContactPatrick J Lamb
CorrespondentPatrick J Lamb
ORION LIFE SYSTEMS, INC. P.O. BOX 2308 Palm Harbor,  FL  34682 -2308
Product CodeJOL  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-05
Decision Date1994-11-21

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