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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialyzer, parallel flow
510(k) Number K915504
Device Name GAMBRO LUNDIA ALPHA HEMODIALYZERS
Applicant
C.G.H. MEDICAL, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Applicant Contact VERA BUFFALOE
Correspondent
C.G.H. MEDICAL, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Correspondent Contact VERA BUFFALOE
Regulation Number876.5820
Classification Product Code
FJG  
Date Received12/09/1991
Decision Date 03/06/1992
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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