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DORA Disposable A.V. Fistula Needle Sets

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163025
510(k) Type
Traditional
Applicant
Bain Medical Equipment (Guangzhou) Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
7/20/2017
Days to Decision
262 days
Submission Type
Summary

DORA Disposable A.V. Fistula Needle Sets

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163025
510(k) Type
Traditional
Applicant
Bain Medical Equipment (Guangzhou) Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
7/20/2017
Days to Decision
262 days
Submission Type
Summary