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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 K971257
Device Name VTU-1 VACUUM ERECTION SYSTEM
Applicant
Mckenna & Cuneo
1900 K St. NW
Washington,  DC  20006
Applicant Contact DONALD R STONE
Correspondent
Mckenna & Cuneo
1900 K St. NW
Washington,  DC  20006
Correspondent Contact DONALD R STONE
Regulation Number876.5020
Classification Product Code
LKY  
Date Received04/04/1997
Decision Date 10/03/1997
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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