Grosz Play Feel

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 Grosz Play Feel.

Pre-market Notification Details

Device IDK211088
510k NumberK211088
Device Name:Grosz Play Feel
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 Received2021-04-12
Decision Date2021-07-09

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