Last synced on 14 June 2024 at 11:05 pm

SpaceOAR System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202224
510(k) Type
Special
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/28/2020
Days to Decision
21 days
Submission Type
Summary

SpaceOAR System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202224
510(k) Type
Special
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/28/2020
Days to Decision
21 days
Submission Type
Summary