Last synced on 30 September 2022 at 11:05 pm

i-ED COIL

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192068
510(k) Type
Traditional
Applicant
Kaneka Pharma America LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/25/2020
Days to Decision
268 days
Submission Type
Summary

i-ED COIL

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192068
510(k) Type
Traditional
Applicant
Kaneka Pharma America LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/25/2020
Days to Decision
268 days
Submission Type
Summary