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

Lubricant, Personal

CC Wellness LLC

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

Pre-market Notification Details

Device IDK210986
510k NumberK210986
Device Name:H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit For Two, JO 2 To Tango For Me, JO 2 To Tango Couples Pleasure Kit
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 Received2021-04-01
Decision Date2021-06-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10796494000172 K210986 000
10796494000707 K210986 000
10796494000745 K210986 000
10796494000738 K210986 000
10796494000691 K210986 000
10796494001667 K210986 000
10796494001414 K210986 000
10796494001483 K210986 000

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