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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 K893991
Device Name HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS
Applicant
P & A CO.
P.O. BOX 10376
SANTA ANA,  CA  92711
Applicant Contact ROBERT ABELS
Correspondent
P & A CO.
P.O. BOX 10376
SANTA ANA,  CA  92711
Correspondent Contact ROBERT ABELS
Regulation Number876.5820
Classification Product Code
KPO  
Date Received06/05/1989
Decision Date 01/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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