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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 K913223
Device Name STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES
Applicant
MEDICAL DEVICE INSPECTION CO., INC.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
MEDICAL DEVICE INSPECTION CO., INC.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number876.5250
Classification Product Code
KNX  
Date Received07/19/1991
Decision Date 09/04/1991
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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