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R2 Studio Q/RCT820

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222219
510(k) Type
Traditional
Applicant
MegaGen Implant CO., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/6/2022
Days to Decision
134 days
Submission Type
Summary

R2 Studio Q/RCT820

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222219
510(k) Type
Traditional
Applicant
MegaGen Implant CO., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/6/2022
Days to Decision
134 days
Submission Type
Summary