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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Penile
510(k) Number K090663
Device Name AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
Applicant
American Medical Systems, Inc.
10700 Bren Rd. W.
Minnetonka,  MN  55343
Applicant Contact STEPHANIE GEORGE
Correspondent
American Medical Systems, Inc.
10700 Bren Rd. W.
Minnetonka,  MN  55343
Correspondent Contact STEPHANIE GEORGE
Regulation Number876.3630
Classification Product Code
FAE  
Date Received03/12/2009
Decision Date 04/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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