XL-4 PAGODA (CONDOMS)

Condom

MAYER LABORATORIES

The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Xl-4 Pagoda (condoms).

Pre-market Notification Details

Device IDK874851
510k NumberK874851
Device Name:XL-4 PAGODA (CONDOMS)
ClassificationCondom
Applicant MAYER LABORATORIES 1611 TELEGRAPH AVENUE, SUITE 830 Oakland,  CA  94612
ContactDavid P Mayer
CorrespondentDavid P Mayer
MAYER LABORATORIES 1611 TELEGRAPH AVENUE, SUITE 830 Oakland,  CA  94612
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-25
Decision Date1988-01-21

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