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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Penile
510(k) Number K803111
Device Name ERECTAID
Applicant
Burditt & Calkins-Siemens-Elema
135 S. Lasalle
Chicago,  IL  60603
Applicant Contact FRANK GEROW
Correspondent
Burditt & Calkins-Siemens-Elema
135 S. Lasalle
Chicago,  IL  60603
Correspondent Contact FRANK GEROW
Regulation Number876.3630
Classification Product Code
FAE  
Date Received12/10/1980
Decision Date 01/23/1981
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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