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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 K904485
Device Name SUPPORT RING
Applicant
Numedtec, Inc.
29475 Hawthorne Ln.
Libertyville,  IL  60048
Applicant Contact PETER MILLER
Correspondent
Numedtec, Inc.
29475 Hawthorne Ln.
Libertyville,  IL  60048
Correspondent Contact PETER MILLER
Regulation Number876.5020
Classification Product Code
LKY  
Date Received10/02/1990
Decision Date 12/14/1990
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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