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URONIRS, MODEL 2000

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082701
510(k) Type
Traditional
Applicant
URODYNAMIX TECHNOLOGIES LTD
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
12/18/2008
Days to Decision
93 days
Submission Type
Summary

URONIRS, MODEL 2000

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082701
510(k) Type
Traditional
Applicant
URODYNAMIX TECHNOLOGIES LTD
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
12/18/2008
Days to Decision
93 days
Submission Type
Summary