AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING

Lubricant, Personal

MAYER LABORATORIES, INC.

The following data is part of a premarket notification filed by Mayer Laboratories, Inc. with the FDA for Aqua Lube Natural Lubricant - Regular, Warming.

Pre-market Notification Details

Device IDK130345
510k NumberK130345
Device Name:AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING
ClassificationLubricant, Personal
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 CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-11
Decision Date2013-08-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20016169530047 K130345 000
20016169530023 K130345 000
10016169515047 K130345 000
20016169515020 K130345 000

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