Last synced on 30 November 2024 at 11:09 am

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221144
510(k) Type
Special
Applicant
Radisen Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
5/13/2022
Days to Decision
23 days
Submission Type
Summary

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221144
510(k) Type
Special
Applicant
Radisen Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
5/13/2022
Days to Decision
23 days
Submission Type
Summary