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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 K843698
Device Name CLOSED URINARY DRAINAGE UNIT
Applicant
Pathfinder Intl. Corp.
P.O. Box 3104
Jacksonville,  FL  32206
Applicant Contact ROBERT E SEAVEY
Correspondent
Pathfinder Intl. Corp.
P.O. Box 3104
Jacksonville,  FL  32206
Correspondent Contact ROBERT E SEAVEY
Regulation Number876.5250
Classification Product Code
KNX  
Date Received09/20/1984
Decision Date 12/17/1984
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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