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CORE1 Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210039
510(k) Type
Traditional
Applicant
Cybermed Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/7/2022
Days to Decision
366 days
Submission Type
Summary

CORE1 Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210039
510(k) Type
Traditional
Applicant
Cybermed Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/7/2022
Days to Decision
366 days
Submission Type
Summary