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I RUNE (I-200L)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122410
510(k) Type
Traditional
Applicant
MEDIRUNE CO, LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
11/12/2013
Days to Decision
461 days
Submission Type
Summary

I RUNE (I-200L)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122410
510(k) Type
Traditional
Applicant
MEDIRUNE CO, LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
11/12/2013
Days to Decision
461 days
Submission Type
Summary