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AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K912935
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/18/1992
Days to Decision
257 days
Submission Type
Summary

AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K912935
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/18/1992
Days to Decision
257 days
Submission Type
Summary