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AugMENTA Penile Implant

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200073
510(k) Type
Traditional
Applicant
Augmenta LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/30/2022
Days to Decision
990 days
Submission Type
Summary

AugMENTA Penile Implant

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200073
510(k) Type
Traditional
Applicant
Augmenta LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/30/2022
Days to Decision
990 days
Submission Type
Summary