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ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K790519
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/14/1979
Days to Decision
59 days

ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K790519
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/14/1979
Days to Decision
59 days