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MODIFICATION TO KOWA NONMYD ALPHA-DIII

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083387
510(k) Type
Special
Applicant
KOWA CO. LTD.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
1/16/2009
Days to Decision
60 days
Submission Type
Summary

MODIFICATION TO KOWA NONMYD ALPHA-DIII

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083387
510(k) Type
Special
Applicant
KOWA CO. LTD.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
1/16/2009
Days to Decision
60 days
Submission Type
Summary