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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accessories, blood circuit, hemodialysis
510(k) Number K760627
Device Name FILTER SET PMF 2168
Applicant
SORENSEN RESEARCH
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
SORENSEN RESEARCH
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number876.5820
Classification Product Code
KOC  
Date Received09/13/1976
Decision Date 10/15/1976
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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