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Endoform Plastics and Reconstructive Matrix

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162461
510(k) Type
Traditional
Applicant
AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED)
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
12/20/2016
Days to Decision
109 days
Submission Type
Summary

Endoform Plastics and Reconstructive Matrix

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162461
510(k) Type
Traditional
Applicant
AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED)
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
12/20/2016
Days to Decision
109 days
Submission Type
Summary