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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 K911603
Device Name HEMOSPAL KIT B22
Applicant
C.G.H. Medical, Inc.
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
C.G.H. Medical, Inc.
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received04/10/1991
Decision Date 08/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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