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AR_N SLA Type Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190641
510(k) Type
Traditional
Applicant
Biotem Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
2/21/2020
Days to Decision
345 days
Submission Type
Summary

AR_N SLA Type Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190641
510(k) Type
Traditional
Applicant
Biotem Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
2/21/2020
Days to Decision
345 days
Submission Type
Summary