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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 K082006
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 Received07/15/2008
Decision Date 10/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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