Unicare (K-UNICARE-USA)— 510(k) K230983

Substantially Equivalent

Tenscare, Ltd.

FDA 510(k) clearance K230983 for Unicare (K-UNICARE-USA), Substantially Equivalent on 2023-10-20. Applicant: Tenscare, Ltd..

Clearance details

Applicant: Tenscare, Ltd.
Product code: Code KPI
Advisory panel: Gastroenterology, Urology
Date received: 2023-04-06
Decision date: 2023-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Epsom, GB

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