Durex Penck Standard, Durex Penck XL

Condom

RB Health (US) LLC

The following data is part of a premarket notification filed by Rb Health (us) Llc with the FDA for Durex Penck Standard, Durex Penck Xl.

Pre-market Notification Details

Device IDK200672
510k NumberK200672
Device Name:Durex Penck Standard, Durex Penck XL
ClassificationCondom
Applicant RB Health (US) LLC 399 Interpace Parkway Parsippany,  NJ  07054
ContactKyle Prince
CorrespondentKyle Prince
RB Health (US) LLC 399 Interpace Parkway Parsippany,  NJ  07054
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-13
Decision Date2020-11-06

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