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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 K912736
Device Name ERECAID(R) SYSTEM PLUS
Applicant
Osbon Medical Systems, Ltd.
Post Office Box 1478
Augusta,  GA  30903
Applicant Contact JULIAN W OSBON
Correspondent
Osbon Medical Systems, Ltd.
Post Office Box 1478
Augusta,  GA  30903
Correspondent Contact JULIAN W OSBON
Regulation Number876.5020
Classification Product Code
LKY  
Date Received06/21/1991
Decision Date 08/12/1991
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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