MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE

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 Modified Fome-cuf Silicone Tracheostomy Tube.

Pre-market Notification Details

Device IDK896547
510k NumberK896547
Device Name:MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
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 Received1989-11-15
Decision Date1990-01-22

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