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OSCAR (OSCAR Prime, OSCAR Classic)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181943
510(k) Type
Traditional
Applicant
Genoray Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/17/2018
Days to Decision
28 days
Submission Type
Summary

OSCAR (OSCAR Prime, OSCAR Classic)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181943
510(k) Type
Traditional
Applicant
Genoray Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/17/2018
Days to Decision
28 days
Submission Type
Summary