BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES

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 Flextend Pediatric & Neonatal Tracheostromy Tubes.

Pre-market Notification Details

Device IDK944178
510k NumberK944178
Device Name:BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
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 Received1994-08-26
Decision Date1994-10-27

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