Durex Penck III Regular

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 Iii Regular.

Pre-market Notification Details

Device IDK222068
510k NumberK222068
Device Name:Durex Penck III Regular
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 Received2022-07-14
Decision Date2022-10-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
99067981087981 K222068 000
50302340876587 K222068 000
50302340876570 K222068 000
10067981087984 K222068 000
10067981087977 K222068 000

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