CONCEIVEX LATEX-FREE SEMEN COLLECTOR

Kit, Conception-assist, Home Use

CONCEIVEX INC.

The following data is part of a premarket notification filed by Conceivex Inc. with the FDA for Conceivex Latex-free Semen Collector.

Pre-market Notification Details

Device IDK080752
510k NumberK080752
Device Name:CONCEIVEX LATEX-FREE SEMEN COLLECTOR
ClassificationKit, Conception-assist, Home Use
Applicant CONCEIVEX INC. 2600 MULLINIX MILL ROAD Mt. Airy,  MD  21771 -0031
ContactBlix Winston
CorrespondentBlix Winston
CONCEIVEX INC. 2600 MULLINIX MILL ROAD Mt. Airy,  MD  21771 -0031
Product CodeOBB  
CFR Regulation Number884.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-17
Decision Date2008-05-14
Summary:summary

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