KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED

Condom

MAYER LABORATORIES, INC.

The following data is part of a premarket notification filed by Mayer Laboratories, Inc. with the FDA for Kimono Microthin With Aqua Lube, Reality Ultra Lubricated.

Pre-market Notification Details

Device IDK113686
510k NumberK113686
Device Name:KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED
ClassificationCondom
Applicant MAYER LABORATORIES, INC. 1950 ADDISON STREET, SUITE 101 Berkely,  CA  94704 -1182
ContactDavid P Mayer
CorrespondentDavid P Mayer
MAYER LABORATORIES, INC. 1950 ADDISON STREET, SUITE 101 Berkely,  CA  94704 -1182
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-15
Decision Date2012-03-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850002174311 K113686 000
00850002174304 K113686 000

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