Personal Lubricating Jelly

Lubricant, Personal

Perrigo New York, Inc.

The following data is part of a premarket notification filed by Perrigo New York, Inc. with the FDA for Personal Lubricating Jelly.

Pre-market Notification Details

Device IDK180923
510k NumberK180923
Device Name:Personal Lubricating Jelly
ClassificationLubricant, Personal
Applicant Perrigo New York, Inc. 1700 Bathgate Ave. Bronx,  NY  10457 -7512
ContactKaren Dombrowski
CorrespondentPhil Triolo
Phil Triolo And Associates LC 86 Skycrest Land Salt Lake City,  UT  84108
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-09
Decision Date2018-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10041220823229 K180923 000

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