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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 K883195
Device Name FRESENIUS F8 DIALYZER
Applicant
FRESENIUS USA, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Applicant Contact THOMAS E CANE
Correspondent
FRESENIUS USA, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Correspondent Contact THOMAS E CANE
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/28/1988
Decision Date 09/13/1988
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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