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MONOFIX PGCL, knotless wound closure device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212810
510(k) Type
Traditional
Applicant
Samyang Holdings Corp., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/5/2022
Days to Decision
336 days
Submission Type
Summary

MONOFIX PGCL, knotless wound closure device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212810
510(k) Type
Traditional
Applicant
Samyang Holdings Corp., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/5/2022
Days to Decision
336 days
Submission Type
Summary