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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tank, holding, dialysis
510(k) Number K003560
Device Name MAR COR SERVICES BICARB SYSTEM
Applicant
MAR COR SERVICES, INC.
364 MAPLE AVE.
HARLEYSVILLE,  PA  19438
Applicant Contact MICHAEL ROBERTSON
Correspondent
MAR COR SERVICES, INC.
364 MAPLE AVE.
HARLEYSVILLE,  PA  19438
Correspondent Contact MICHAEL ROBERTSON
Regulation Number876.5820
Classification Product Code
FIN  
Date Received11/17/2000
Decision Date 06/08/2001
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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