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iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193522
510(k) Type
Traditional
Applicant
Kitazato Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
8/25/2020
Days to Decision
250 days
Submission Type
Summary

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193522
510(k) Type
Traditional
Applicant
Kitazato Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
8/25/2020
Days to Decision
250 days
Submission Type
Summary