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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 K832043
Device Name SURGIKEK PENILE PROSTHESIS TAIL EXTEND
Applicant
MEDICAL ENGINEERING CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDICAL ENGINEERING CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.3630
Classification Product Code
FAE  
Date Received06/24/1983
Decision Date 10/20/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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