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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 K855209
Device Name NIR LAT MALE EXTERNAL CATHETER
Applicant
MALI, INC.
18455 BURBACK BLVD, STE 411
TARZANA,  CA  91356
Applicant Contact COROLE HIRSCH
Correspondent
MALI, INC.
18455 BURBACK BLVD, STE 411
TARZANA,  CA  91356
Correspondent Contact COROLE HIRSCH
Regulation Number876.5250
Classification Product Code
KNX  
Date Received12/30/1985
Decision Date 01/10/1986
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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