SUPER MAXX OTHERS (MULTIPLE) CONDOMS

Condom

MAYER LABORATORIES

The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Super Maxx Others (multiple) Condoms.

Pre-market Notification Details

Device IDK884468
510k NumberK884468
Device Name:SUPER MAXX OTHERS (MULTIPLE) 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 Received1988-10-25
Decision Date1989-03-31

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