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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tray, start/stop (including contents), dialysis
510(k) Number K925469
Device Name JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT
Applicant
J.J. SKINNER, INC.
C/O MEDICAL DEVICE INSPECTION
55 NORTHERN BLVD., SUITE 301
GREAT NECK,  NY  11021
Applicant Contact CAROLANN KOTULA-COOK
Correspondent
J.J. SKINNER, INC.
C/O MEDICAL DEVICE INSPECTION
55 NORTHERN BLVD., SUITE 301
GREAT NECK,  NY  11021
Correspondent Contact CAROLANN KOTULA-COOK
Regulation Number876.5820
Classification Product Code
FKG  
Date Received10/29/1992
Decision Date 05/03/1995
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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