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700 ULTREX PENILE PROSTHESIS 12MM DIAMETER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K901482
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/27/1990
Days to Decision
90 days

700 ULTREX PENILE PROSTHESIS 12MM DIAMETER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K901482
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/27/1990
Days to Decision
90 days