K-Y BRAND LIQUIBEADS

Lubricant, Personal

JOHNSON & JOHNSON HEALTHCARE PRODUCTS

The following data is part of a premarket notification filed by Johnson & Johnson Healthcare Products with the FDA for K-y Brand Liquibeads.

Pre-market Notification Details

Device IDK122061
510k NumberK122061
Device Name:K-Y BRAND LIQUIBEADS
ClassificationLubricant, Personal
Applicant JOHNSON & JOHNSON HEALTHCARE PRODUCTS 185 TABOR ROAD Morris Plains,  NJ  07950
ContactLorna-jane Bremer
CorrespondentLorna-jane Bremer
JOHNSON & JOHNSON HEALTHCARE PRODUCTS 185 TABOR ROAD Morris Plains,  NJ  07950
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-13
Decision Date2013-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20067981160462 K122061 000

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