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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 K863739
Device Name BESCURE
Applicant
U-T, Inc.
300 Industrial Pky P.O. 0675
Chagrin Falls,  OH  44022
Applicant Contact RICHARD G BAERMAN
Correspondent
U-T, Inc.
300 Industrial Pky P.O. 0675
Chagrin Falls,  OH  44022
Correspondent Contact RICHARD G BAERMAN
Regulation Number876.5250
Classification Product Code
KNX  
Date Received09/23/1986
Decision Date 10/24/1986
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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