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INNO SLA Submerged Hybrid Ti-Base System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231411
510(k) Type
Traditional
Applicant
Cowellmedi Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/20/2023
Days to Decision
218 days
Submission Type
Summary

INNO SLA Submerged Hybrid Ti-Base System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231411
510(k) Type
Traditional
Applicant
Cowellmedi Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/20/2023
Days to Decision
218 days
Submission Type
Summary