CHEST DRAINAGE TUBING

Tubing, Pump, Cardiopulmonary Bypass

OLSON MEDICAL SALES, INC.

The following data is part of a premarket notification filed by Olson Medical Sales, Inc. with the FDA for Chest Drainage Tubing.

Pre-market Notification Details

Device IDK993062
510k NumberK993062
Device Name:CHEST DRAINAGE TUBING
ClassificationTubing, Pump, Cardiopulmonary Bypass
Applicant OLSON MEDICAL SALES, INC. 2101 COTTONTAIL LN. Somerset,  NJ  08873
ContactGarry A Courtney
CorrespondentGarry A Courtney
OLSON MEDICAL SALES, INC. 2101 COTTONTAIL LN. Somerset,  NJ  08873
Product CodeDWE  
CFR Regulation Number870.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-13
Decision Date1999-12-10
Summary:summary

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