K-Y LUBRICATING JELLY

Lubricant, Patient

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for K-y Lubricating Jelly.

Pre-market Notification Details

Device IDK810310
510k NumberK810310
Device Name:K-Y LUBRICATING JELLY
ClassificationLubricant, Patient
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeKMJ  
CFR Regulation Number880.6375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-02-05
Decision Date1981-04-21

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