Durex Penck III Regular— 510(k) K222068

Substantially Equivalent

Rb Health (Us), LLC

FDA 510(k) clearance K222068 for Durex Penck III Regular, Substantially Equivalent on 2022-10-12. Applicant: Rb Health (Us), LLC.

Clearance details

Applicant: Rb Health (Us), LLC
Product code: Code HIS
Advisory panel: Obstetrics/Gynecology
Date received: 2022-07-14
Decision date: 2022-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

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