K-number	K200672
Device name	Durex Penck Standard, Durex Penck XL
Applicant	Rb Health (Us), LLC
Product code	HIS
Device class	Class II
Decision date	Nov 6, 2020
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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Durex Penck Standard, Durex Penck XL

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