AJDJUSTABLE SUCTION CONTROL VALVE

Suction Control, Intracardiac, 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 Ajdjustable Suction Control Valve.

Pre-market Notification Details

Device IDK851406
510k NumberK851406
Device Name:AJDJUSTABLE SUCTION CONTROL VALVE
ClassificationSuction Control, Intracardiac, 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 CodeDWD  
CFR Regulation Number870.4430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-09
Decision Date1985-08-05

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