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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K861106
Device Name FRESENIUS HEMOFLOW F80 DIALYZER
Applicant
SERATRONICS, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Applicant Contact SCOTT N WALKER
Correspondent
SERATRONICS, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Correspondent Contact SCOTT N WALKER
Regulation Number876.5860
Classification Product Code
KDI  
Date Received03/24/1986
Decision Date 04/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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