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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 K020230
Device Name DIASOL-BICARB
Applicant
DIASOL, INC.
13212 RAYMER ST.
NORTH HOLLYWOOD,  CA  91605
Applicant Contact MONICA ABELES
Correspondent
DIASOL, INC.
13212 RAYMER ST.
NORTH HOLLYWOOD,  CA  91605
Correspondent Contact MONICA ABELES
Regulation Number876.5820
Classification Product Code
KPO  
Date Received01/23/2002
Decision Date 04/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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