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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 K904406
Device Name EER ERECTION ENHANCED RESPONDER
Applicant
Eer, Inc.
901 Charles St.
Mechanicsburg,  PA  17055
Applicant Contact RUDOLPH YANUCK
Correspondent
Eer, Inc.
901 Charles St.
Mechanicsburg,  PA  17055
Correspondent Contact RUDOLPH YANUCK
Regulation Number876.5020
Classification Product Code
LKY  
Date Received09/24/1990
Decision Date 02/25/1991
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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