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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 K832543
Device Name MALE THERAPEUTIC POTENT AID
Applicant
Mace'S Scientific
5245 Challedon Dr.
Virginia Beach,  VA  23462
Applicant Contact JAMES E MACE
Correspondent
Mace'S Scientific
5245 Challedon Dr.
Virginia Beach,  VA  23462
Correspondent Contact JAMES E MACE
Regulation Number876.5020
Classification Product Code
LKY  
Date Received07/29/1983
Decision Date 12/27/1983
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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