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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 K823338
Device Name COBE HEMOCONCENTRATOR 1.3
Applicant
COBE LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
COBE LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5860
Classification Product Code
KDI  
Date Received11/08/1982
Decision Date 01/07/1983
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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