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S-Line

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182193
510(k) Type
Traditional
Applicant
BIO CETEC CO., LTD.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/22/2019
Days to Decision
161 days
Submission Type
Summary

S-Line

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182193
510(k) Type
Traditional
Applicant
BIO CETEC CO., LTD.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/22/2019
Days to Decision
161 days
Submission Type
Summary