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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 K882531
Device Name MODIFIED L.J.'S SEX HELPER
Applicant
L.J. Fant & Co.
314 Valley St.
Glencoe,  AL  35905
Applicant Contact LOWELL J FANT
Correspondent
L.J. Fant & Co.
314 Valley St.
Glencoe,  AL  35905
Correspondent Contact LOWELL J FANT
Regulation Number876.5020
Classification Product Code
LKY  
Date Received06/22/1988
Decision Date 12/08/1988
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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