KY Banksy Moisture

Lubricant, Personal

RB Health (US) LLC

The following data is part of a premarket notification filed by Rb Health (us) Llc with the FDA for Ky Banksy Moisture.

Pre-market Notification Details

Device IDK183505
510k NumberK183505
Device Name:KY Banksy Moisture
ClassificationLubricant, Personal
Applicant RB Health (US) LLC 399 Interpace Parkway Parsippany,  NJ  07054
ContactElizabeth Viguerie
CorrespondentElizabeth Viguerie
RB Health (US) LLC 399 Interpace Parkway Parsippany,  NJ  07054
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-18
Decision Date2019-05-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10067981096771 K183505 000
20067981096709 K183505 000
00067981096774 K183505 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.