SILENT GUARD CAT. NO. SG-10

Adaptor, Stopcock, Manifold, Fitting, 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 Silent Guard Cat. No. Sg-10.

Pre-market Notification Details

Device IDK873488
510k NumberK873488
Device Name:SILENT GUARD CAT. NO. SG-10
ClassificationAdaptor, Stopcock, Manifold, Fitting, 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 CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-31
Decision Date1987-10-07

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