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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 K843117
Device Name GREEN CROSS URINARY DRAINAGE BAG
Applicant
Tech-Cons Ltd., Intl.
P.O. Box 59295
Chicago,  IL  60659
Applicant Contact GEORGE F GREENE
Correspondent
Tech-Cons Ltd., Intl.
P.O. Box 59295
Chicago,  IL  60659
Correspondent Contact GEORGE F GREENE
Regulation Number876.5250
Classification Product Code
KNX  
Date Received08/08/1984
Decision Date 10/11/1984
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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