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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 K901223
Device Name VACUUM ERECTION DEVICE (VED)
Applicant
Mission Pharmacal Co.
P.O. Box 1676
San Antonio,  TX  78296
Applicant Contact GEORGE ALEXANDRIDES
Correspondent
Mission Pharmacal Co.
P.O. Box 1676
San Antonio,  TX  78296
Correspondent Contact GEORGE ALEXANDRIDES
Regulation Number876.5020
Classification Product Code
LKY  
Date Received03/14/1990
Decision Date 05/04/1990
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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