LABELLING MODIFICATION TO MAXX PLUS

Condom

MAYER LABORATORIES

The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Labelling Modification To Maxx Plus.

Pre-market Notification Details

Device IDK904453
510k NumberK904453
Device Name:LABELLING MODIFICATION TO MAXX PLUS
ClassificationCondom
Applicant MAYER LABORATORIES 231 FALLON ST. Oakland,  CA  94607
ContactDavid P Mayer
CorrespondentDavid P Mayer
MAYER LABORATORIES 231 FALLON ST. Oakland,  CA  94607
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-27
Decision Date1990-11-23

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