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EXALT Model D Single-Use Duodenoscope, EXALT Controller

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193202
510(k) Type
Traditional
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/13/2019
Days to Decision
23 days
Submission Type
Summary

EXALT Model D Single-Use Duodenoscope, EXALT Controller

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193202
510(k) Type
Traditional
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/13/2019
Days to Decision
23 days
Submission Type
Summary