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SpaceOAR Vue Hydrogel

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182971
510(k) Type
Traditional
Applicant
Augmenix, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/19/2019
Days to Decision
266 days
Submission Type
Summary

SpaceOAR Vue Hydrogel

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182971
510(k) Type
Traditional
Applicant
Augmenix, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/19/2019
Days to Decision
266 days
Submission Type
Summary