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SpaceOAR System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN140030
510(k) Type
Direct
Applicant
AUGMENIX , INC.
Country
United States
FDA Decision
Deleted
Decision Date
4/1/2015
Days to Decision
182 days

SpaceOAR System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN140030
510(k) Type
Direct
Applicant
AUGMENIX , INC.
Country
United States
FDA Decision
Deleted
Decision Date
4/1/2015
Days to Decision
182 days