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ANDORATE® Suction Valve and ANDORATE® Biopsy Valve

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230280
510(k) Type
Traditional
Applicant
GA Health Company Limited
Country
Hong Kong SAR China
FDA Decision
Substantially Equivalent
Decision Date
5/11/2023
Days to Decision
99 days
Submission Type
Summary

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230280
510(k) Type
Traditional
Applicant
GA Health Company Limited
Country
Hong Kong SAR China
FDA Decision
Substantially Equivalent
Decision Date
5/11/2023
Days to Decision
99 days
Submission Type
Summary