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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 K904262
Device Name MINNOW PENILE IMPLANT PROTECTOR
Applicant
Ruja-Med Medical Marketing
1401 University Dr.
Coral Springs,  FL  33071
Applicant Contact PAUL K BERMAN
Correspondent
Ruja-Med Medical Marketing
1401 University Dr.
Coral Springs,  FL  33071
Correspondent Contact PAUL K BERMAN
Regulation Number876.3630
Classification Product Code
FAE  
Date Received09/14/1990
Decision Date 12/13/1990
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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