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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 K760069
Device Name BAG, LEG, URINE COLLECTING DEVICE
Applicant
Pharmaseal Div., Baxter Healthcare Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pharmaseal Div., Baxter Healthcare Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5250
Classification Product Code
KNX  
Date Received06/16/1976
Decision Date 10/20/1976
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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