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Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193325
510(k) Type
Traditional
Applicant
ProSys International Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
3/13/2020
Days to Decision
102 days
Submission Type
Summary