BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.

Tube Tracheostomy And Tube Cuff

BIVONA MEDICAL TECHNOLOGIES

The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Bivona Aire-cuf Tracheostomy Tube W/talk Attach..

Pre-market Notification Details

Device IDK912967
510k NumberK912967
Device Name:BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.
ClassificationTube Tracheostomy And Tube Cuff
Applicant BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary,  IN  46406
ContactHarry M.kaufman
CorrespondentHarry M.kaufman
BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary,  IN  46406
Product CodeJOH  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-08
Decision Date1991-07-17

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