PRESSURE BARRIER KIT CAT. NO. PBK-3

Gauge, Pressure, Coronary, Cardiopulmonary Bypass

AMERICAN OMNI MEDICAL, INC.

The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Pressure Barrier Kit Cat. No. Pbk-3.

Pre-market Notification Details

Device IDK873802
510k NumberK873802
Device Name:PRESSURE BARRIER KIT CAT. NO. PBK-3
ClassificationGauge, Pressure, Coronary, Cardiopulmonary Bypass
Applicant AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa,  CA  92626
ContactGeorge G Siposs
CorrespondentGeorge G Siposs
AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa,  CA  92626
Product CodeDXS  
CFR Regulation Number870.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-18
Decision Date1987-11-06

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