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Fusion OMNI Sphincterotome

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172288
510(k) Type
Traditional
Applicant
Wilson-Cook Medical, Inc./ Cook Endoscopy
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/17/2018
Days to Decision
260 days
Submission Type
Summary

Fusion OMNI Sphincterotome

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172288
510(k) Type
Traditional
Applicant
Wilson-Cook Medical, Inc./ Cook Endoscopy
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/17/2018
Days to Decision
260 days
Submission Type
Summary