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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 K974173
Device Name ERECAID SYSTEM/STAY EREC SYSTEM
Applicant
IMAGYN MEDICAL TECHNOLOGIES, INC.
5 CIVIC PLAZA, SUITE 100
NEWPORT BEACH,  CA  92660
Applicant Contact RONALD H BERGESON
Correspondent
IMAGYN MEDICAL TECHNOLOGIES, INC.
5 CIVIC PLAZA, SUITE 100
NEWPORT BEACH,  CA  92660
Correspondent Contact RONALD H BERGESON
Regulation Number876.5020
Classification Product Code
LKY  
Date Received11/05/1997
Decision Date 02/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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