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Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182259
510(k) Type
Traditional
Applicant
ACell, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/7/2019
Days to Decision
170 days
Submission Type
Summary

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182259
510(k) Type
Traditional
Applicant
ACell, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/7/2019
Days to Decision
170 days
Submission Type
Summary