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ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151437
510(k) Type
Traditional
Applicant
ATRIUM MEDICAL CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/27/2015
Days to Decision
90 days
Submission Type
Summary

ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151437
510(k) Type
Traditional
Applicant
ATRIUM MEDICAL CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/27/2015
Days to Decision
90 days
Submission Type
Summary