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Closed System Transfer Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201460
510(k) Type
Traditional
Applicant
Shinva Ande Healthcare Apparatus Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
11/23/2022
Days to Decision
904 days
Submission Type
Summary

Closed System Transfer Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201460
510(k) Type
Traditional
Applicant
Shinva Ande Healthcare Apparatus Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
11/23/2022
Days to Decision
904 days
Submission Type
Summary