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AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K910214
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/25/1991
Days to Decision
98 days

AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K910214
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/25/1991
Days to Decision
98 days