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Endoform Reconstructive Template

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153632
510(k) Type
Traditional
Applicant
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
6/16/2016
Days to Decision
181 days
Submission Type
Summary

Endoform Reconstructive Template

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153632
510(k) Type
Traditional
Applicant
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
6/16/2016
Days to Decision
181 days
Submission Type
Summary