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Biopor Porous Polyethylene Implants

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161446
510(k) Type
Traditional
Applicant
Ceremed , Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/27/2016
Days to Decision
125 days
Submission Type
Summary

Biopor Porous Polyethylene Implants

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161446
510(k) Type
Traditional
Applicant
Ceremed , Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/27/2016
Days to Decision
125 days
Submission Type
Summary