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REXLENE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173747
510(k) Type
Traditional
Applicant
SM ENG CO., LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/21/2018
Days to Decision
378 days
Submission Type
Summary

REXLENE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173747
510(k) Type
Traditional
Applicant
SM ENG CO., LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/21/2018
Days to Decision
378 days
Submission Type
Summary