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Flap Fixator, Burr Hole Cover

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192310
510(k) Type
Traditional
Applicant
Ossaware Biotech Co., Ltd.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
6/3/2020
Days to Decision
282 days
Submission Type
Summary

Flap Fixator, Burr Hole Cover

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192310
510(k) Type
Traditional
Applicant
Ossaware Biotech Co., Ltd.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
6/3/2020
Days to Decision
282 days
Submission Type
Summary