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Bowel Management Device, Bowel Management Irrigation Set

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180026
510(k) Type
Traditional
Applicant
Applied Medical Technology, Inc.
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
6/1/2018
Days to Decision
149 days
Submission Type
Summary