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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K913142
Device Name BODEN WHEELCHAIR DRAINAGE SYSTEM
Applicant
Mno Medical Products
441 Cedarhaven Way
Anaheim,  CA  92807
Applicant Contact JOHN BODEN
Correspondent
Mno Medical Products
441 Cedarhaven Way
Anaheim,  CA  92807
Correspondent Contact JOHN BODEN
Regulation Number876.5250
Classification Product Code
KNX  
Date Received07/16/1991
Decision Date 09/23/1991
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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