BLOW-SINGER TRACHEOSTOMA VALVE

Prosthesis, Laryngeal (taub)

BIVONA MEDICAL TECHNOLOGIES

The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Blow-singer Tracheostoma Valve.

Pre-market Notification Details

Device IDK821568
510k NumberK821568
Device Name:BLOW-SINGER TRACHEOSTOMA VALVE
ClassificationProsthesis, Laryngeal (taub)
Applicant BIVONA MEDICAL TECHNOLOGIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEWL  
CFR Regulation Number874.3730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-05-27
Decision Date1982-07-26

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