DELTA D-750 THERMAFLOW

Oxygenator, Cardiopulmonary Bypass

DELTA MEDICAL INDUSTRIES

The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Delta D-750 Thermaflow.

Pre-market Notification Details

Device IDK790406
510k NumberK790406
Device Name:DELTA D-750 THERMAFLOW
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-02-26
Decision Date1979-11-13

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