CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)

Condom

MAYER LABORATORIES

The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Condoms (hombre Black/black Satin/xt-12/orion).

Pre-market Notification Details

Device IDK872356
510k NumberK872356
Device Name:CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)
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 Received1987-06-18
Decision Date1988-04-06

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