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Optima Coil System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172390
510(k) Type
Traditional
Applicant
Blockade Medical, LLC (d.b.a. Balt USA)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/18/2018
Days to Decision
194 days
Submission Type
Summary

Optima Coil System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172390
510(k) Type
Traditional
Applicant
Blockade Medical, LLC (d.b.a. Balt USA)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/18/2018
Days to Decision
194 days
Submission Type
Summary