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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 K830192
Device Name MAC LEE UI URINE COLLECTION BAG
Applicant
Mac Lee Medical Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Mac Lee Medical Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5250
Classification Product Code
KNX  
Date Received01/20/1983
Decision Date 02/01/1983
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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