FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN

Gauze/sponge, Internal

RITMED, INC.

The following data is part of a premarket notification filed by Ritmed, Inc. with the FDA for Floret Cylindrical/bronchoscopic/lamin.

Pre-market Notification Details

Device IDK830268
510k NumberK830268
Device Name:FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN
ClassificationGauze/sponge, Internal
Applicant RITMED, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-25
Decision Date1983-06-08

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