WARMING LIQUID PERSONAL LUBRICANT

Lubricant, Personal

PHARMAPAC LLC

The following data is part of a premarket notification filed by Pharmapac Llc with the FDA for Warming Liquid Personal Lubricant.

Pre-market Notification Details

Device IDK052974
510k NumberK052974
Device Name:WARMING LIQUID PERSONAL LUBRICANT
ClassificationLubricant, Personal
Applicant PHARMAPAC LLC 110 INDUSTRIAL PARK ROAD Dekalb,  MS  39329
ContactTom Otto
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-10-24
Decision Date2005-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00084579128587 K052974 000
50050428539519 K052974 000

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