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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 K954527
Device Name ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS
Applicant
ROCKWELL MEDICAL SUPPLY
28025 OAKLAND OAKS CT.
WIXOM,  MI  48393
Applicant Contact JEFFREY R SHIDERMAN
Correspondent
ROCKWELL MEDICAL SUPPLY
28025 OAKLAND OAKS CT.
WIXOM,  MI  48393
Correspondent Contact JEFFREY R SHIDERMAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received09/29/1995
Decision Date 03/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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