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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 K851471
Device Name TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR
Applicant
Lic-Orthion
Rodney R. Munsey
2101 L St. NW
Washington,  DC  20037
Applicant Contact RODNEY R MUNSEY
Correspondent
Lic-Orthion
Rodney R. Munsey
2101 L St. NW
Washington,  DC  20037
Correspondent Contact RODNEY R MUNSEY
Regulation Number876.5250
Classification Product Code
KNX  
Date Received04/15/1985
Decision Date 06/12/1985
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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