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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K923046
Device Name BIOLOGIC DT-1000 MACHINE
Applicant
HEMOCLEANSE, INC.
2701 B KENT AVE.
WEST LAFAYETTE,  IN  47906
Applicant Contact STEPHEN R ASH
Correspondent
HEMOCLEANSE, INC.
2701 B KENT AVE.
WEST LAFAYETTE,  IN  47906
Correspondent Contact STEPHEN R ASH
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/24/1992
Decision Date 09/30/1994
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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