CAVOMAT

Device, Erectile Dysfunction

WIEST USA, INC.

The following data is part of a premarket notification filed by Wiest Usa, Inc. with the FDA for Cavomat.

Pre-market Notification Details

Device IDK911388
510k NumberK911388
Device Name:CAVOMAT
ClassificationDevice, Erectile Dysfunction
Applicant WIEST USA, INC. 9109 COPENHAVER DR. Potomac,  MD  20854
ContactNorman F Estrin
CorrespondentNorman F Estrin
WIEST USA, INC. 9109 COPENHAVER DR. Potomac,  MD  20854
Product CodeLST  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-29
Decision Date1991-12-04

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