Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant

Lubricant, Personal

CC Wellness LLC

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

Pre-market Notification Details

Device IDK200602
510k NumberK200602
Device Name:Premium Cooling Personal Lubricant, Premium Anal Cooling 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 Received2020-03-09
Decision Date2020-06-03

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