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TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192339
510(k) Type
Traditional
Applicant
Wilson-Cook Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/30/2020
Days to Decision
155 days
Submission Type
Summary

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192339
510(k) Type
Traditional
Applicant
Wilson-Cook Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/30/2020
Days to Decision
155 days
Submission Type
Summary