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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 K914557
Device Name ECONOAID
Applicant
Gromedco
P.O. Box 310521
New Braunfels,  TX  78131
Applicant Contact GERALD K GROVES
Correspondent
Gromedco
P.O. Box 310521
New Braunfels,  TX  78131
Correspondent Contact GERALD K GROVES
Regulation Number876.5020
Classification Product Code
LKY  
Date Received10/15/1991
Decision Date 01/23/1992
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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