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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, External Penile Rigidity
510(k) Number K003115
Device Name ACTIS ADJUSTABLE CONSTRICTION LOOP
Applicant
Vivus, Inc.
1172 Castro St.
Mountain View,  CA  94040
Applicant Contact CAROL D KARP
Correspondent
Vivus, Inc.
1172 Castro St.
Mountain View,  CA  94040
Correspondent Contact CAROL D KARP
Regulation Number876.5020
Classification Product Code
LKY  
Date Received10/02/2000
Decision Date 12/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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