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ZIRACE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K051501
510(k) Type
Traditional
Applicant
ACUCERA, INC.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/19/2005
Days to Decision
135 days
Submission Type
Summary

ZIRACE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K051501
510(k) Type
Traditional
Applicant
ACUCERA, INC.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/19/2005
Days to Decision
135 days
Submission Type
Summary