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SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172197
510(k) Type
Traditional
Applicant
ORIGIO a/s
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
10/13/2017
Days to Decision
84 days
Submission Type
Summary

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172197
510(k) Type
Traditional
Applicant
ORIGIO a/s
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
10/13/2017
Days to Decision
84 days
Submission Type
Summary