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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 K931720
Device Name LUNDIA ALPHA 700 HEMODIALYZER
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 Number876.5860
Classification Product Code
KDI  
Date Received04/07/1993
Decision Date 07/07/1994
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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