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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
510(k) Number K813388
FOIA Releasable 510(k) K813388
Device Name HEMODIALYSATE
Applicant
Edlaw Pharmaceuticals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Edlaw Pharmaceuticals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5820
Classification Product Code
KPO  
Date Received12/02/1981
Decision Date 12/31/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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