K230932

Substantially Equivalent

ANDORATE® Valve Kit

Applicant: Ga Health Company Limited
Product code: OCX
Advisory panel: Gastroenterology, Urology
Date received: 2023-04-03
Decision date: 2023-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.