Agape Cooling Personal Lubricant

Lubricant, Personal

CC Wellness LLC

The following data is part of a premarket notification filed by Cc Wellness Llc with the FDA for Agape Cooling Personal Lubricant.

Pre-market Notification Details

Device IDK200894
510k NumberK200894
Device Name:Agape Cooling Personal Lubricant
ClassificationLubricant, Personal
Applicant CC Wellness LLC 29000 N. Hancock Pkwy. Valencia,  CA  91355
ContactMarlent Perez
CorrespondentMarlent Perez
CC Wellness LLC 29000 N. Hancock Pkwy. Valencia,  CA  91355
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-03
Decision Date2020-07-02

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