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AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K896941
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/6/1990
Days to Decision
83 days

AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K896941
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/6/1990
Days to Decision
83 days