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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 K896357
Device Name SAFE AID DEVICE IMPOTENCE DEVICE
Applicant
Dr. John P. March
3759 Erlewine Cir.
Sacramento,  CA  95819
Applicant Contact JOHN P MARCH
Correspondent
Dr. John P. March
3759 Erlewine Cir.
Sacramento,  CA  95819
Correspondent Contact JOHN P MARCH
Regulation Number876.5020
Classification Product Code
LKY  
Date Received11/06/1989
Decision Date 04/25/1990
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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