BUBBLE TRAP CAT. NO. B-180

Catheter, Cannula And Tubing, Vascular, 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 Bubble Trap Cat. No. B-180.

Pre-market Notification Details

Device IDK870819
510k NumberK870819
Device Name:BUBBLE TRAP CAT. NO. B-180
ClassificationCatheter, Cannula And Tubing, Vascular, 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 CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-03
Decision Date1987-06-08

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