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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, dialysate delivery, central multiple patient
510(k) Number K844750
Device Name FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD
Applicant
SERATRONICS, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Applicant Contact BEN J LIPPS
Correspondent
SERATRONICS, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Correspondent Contact BEN J LIPPS
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received12/06/1984
Decision Date 02/15/1985
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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