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SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K120524
510(k) Type
Traditional
Applicant
MUI SCIENTIFIC
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
6/21/2012
Days to Decision
120 days
Submission Type
Summary

SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K120524
510(k) Type
Traditional
Applicant
MUI SCIENTIFIC
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
6/21/2012
Days to Decision
120 days
Submission Type
Summary