BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES

Tube Tracheostomy And Tube Cuff

SMITHS MEDICAL ASD, INC.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Bivona Adjustable And Fixed Neckflange Hyperflex Tracheostomy Tubes.

Pre-market Notification Details

Device IDK081440
510k NumberK081440
Device Name:BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
ClassificationTube Tracheostomy And Tube Cuff
Applicant SMITHS MEDICAL ASD, INC. 6250 SHIER RINGS RD. Dublin,  OH  43016
ContactBarbara Law
CorrespondentBarbara Law
SMITHS MEDICAL ASD, INC. 6250 SHIER RINGS RD. Dublin,  OH  43016
Product CodeJOH  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-22
Decision Date2008-09-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05021312013781 K081440 000
15021312013832 K081440 000
15021312013825 K081440 000
15021312013818 K081440 000
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15021312013726 K081440 000
15021312013719 K081440 000
15021312013702 K081440 000
15021312013696 K081440 000
15021312013849 K081440 000
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15021312013863 K081440 000
05021312013774 K081440 000
05021312013767 K081440 000
05021312013750 K081440 000
15021312015706 K081440 000
15021312015690 K081440 000
15021312015683 K081440 000
15021312015676 K081440 000
15021312015669 K081440 000
15021312015652 K081440 000
15021312015645 K081440 000
15021312015638 K081440 000
15021312013689 K081440 000

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