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Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222602
510(k) Type
Traditional
Applicant
Zhuhai Pusen Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/26/2022
Days to Decision
28 days
Submission Type
Summary

Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222602
510(k) Type
Traditional
Applicant
Zhuhai Pusen Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/26/2022
Days to Decision
28 days
Submission Type
Summary