H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango For You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit For Two

Lubricant, Personal

CC Wellness LLC

The following data is part of a premarket notification filed by Cc Wellness Llc with the FDA for H2o Warming Personal Lubricant, H2o Anal Warming Personal Lubricant, Jo 2 To Tango For You, Jo 2 To Tango Couples Pleasure Kit, #lubelife Sensations Warming, #lubelife Sensations Pleasure Kit For Two.

Pre-market Notification Details

Device IDK210972
510k NumberK210972
Device Name:H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango For You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit For Two
ClassificationLubricant, Personal
Applicant CC Wellness LLC 29000 N. Hancock Pkwy. Valencia,  CA  91344
ContactMarlent Perez
CorrespondentMarlent Perez
CC Wellness LLC 29000 N. Hancock Pkwy. Valencia,  CA  91344
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-31
Decision Date2021-06-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10796494000424 K210972 000
10796494001407 K210972 000
10796494001490 K210972 000
10796494001674 K210972 000
10796494000981 K210972 000
10796494000523 K210972 000
10796494000530 K210972 000
10796494000431 K210972 000
10796494000448 K210972 000
10796494003715 K210972 000

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