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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, Powered, Non Indwelling Catheter
510(k) Number K062061
Device Name URASSIST
Applicant
PREFERRED MEDICAL DEVICES, INC.
8 GRAY LODGE ROAD
KITTERY,  ME  03904
Applicant Contact PENELOPE GRECO
Correspondent
PREFERRED MEDICAL DEVICES, INC.
8 GRAY LODGE ROAD
KITTERY,  ME  03904
Correspondent Contact PENELOPE GRECO
Regulation Number876.5250
Classification Product Code
NZU  
Date Received07/20/2006
Decision Date 10/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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