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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 K872857
Device Name HOSPAL DIALYSATE FOR C.A.V.H.D.
Applicant
Delmed, Inc.
Po Drawer 190
Freehold,  NJ  07728
Applicant Contact A. P DOERSCHUK
Correspondent
Delmed, Inc.
Po Drawer 190
Freehold,  NJ  07728
Correspondent Contact A. P DOERSCHUK
Regulation Number876.5820
Classification Product Code
KPO  
Date Received07/21/1987
Decision Date 10/05/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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