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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 K860336
Device Name HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS
Applicant
Breem Laboratories
8931 S. Vermont Ave.
Los Angeles,  CA  90044
Applicant Contact JAMES STEWART
Correspondent
Breem Laboratories
8931 S. Vermont Ave.
Los Angeles,  CA  90044
Correspondent Contact JAMES STEWART
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received01/29/1986
Decision Date 03/04/1986
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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