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FITme Customized Silicone Implant

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232593
510(k) Type
Traditional
Applicant
Keosan Trading Co.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
11/22/2023
Days to Decision
89 days
Submission Type
Summary

FITme Customized Silicone Implant

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232593
510(k) Type
Traditional
Applicant
Keosan Trading Co.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
11/22/2023
Days to Decision
89 days
Submission Type
Summary