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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, pediatric, for indwelling catheter
510(k) Number K871789
Device Name INTECARE PEDIATRIC URINE COLLECTOR
Applicant
MERCURY ENTERPRISES, INC.
1303 CLEAR SPRINGS TRACE,
SUITE 207
LOUISVILLE,  KY  40223
Applicant Contact WILLIAM J MASON
Correspondent
MERCURY ENTERPRISES, INC.
1303 CLEAR SPRINGS TRACE,
SUITE 207
LOUISVILLE,  KY  40223
Correspondent Contact WILLIAM J MASON
Regulation Number876.5250
Classification Product Code
FFH  
Date Received05/06/1987
Decision Date 08/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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