PRESSURE MONITORING INJECTION LINES

Catheter, Intravascular, Diagnostic

COBE LABORATORIES, INC.

The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Pressure Monitoring Injection Lines.

Pre-market Notification Details

Device IDK781558
510k NumberK781558
Device Name:PRESSURE MONITORING INJECTION LINES
ClassificationCatheter, Intravascular, Diagnostic
Applicant COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-09-11
Decision Date1978-10-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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