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510(k) K200672

Durex Penck Standard, Durex Penck XL by Rb Health (Us), LLC — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2020
Date Received
March 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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