Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming

Lubricant, Personal

CC Wellness LLC

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

Pre-market Notification Details

Device IDK200457
510k NumberK200457
Device Name:Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming
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 Received2020-02-25
Decision Date2020-05-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10796494000417 K200457 000
10796494000400 K200457 000
10796494000998 K200457 000

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