Last synced on 30 November 2024 at 11:09 am

Optima Coil System (OptiBlock Line Extension)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K242582
510(k) Type
Special
Applicant
Balt USA, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/27/2024
Days to Decision
28 days
Submission Type
Summary

Optima Coil System (OptiBlock Line Extension)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K242582
510(k) Type
Special
Applicant
Balt USA, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/27/2024
Days to Decision
28 days
Submission Type
Summary