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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Hemoperfusion, Sorbent
510(k) Number K984546
Device Name BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
Applicant
Hemocleanse, Inc.
2700 Kent Ave.
West Lafayette,  IN  47906
Applicant Contact STEPHEN R ASH
Correspondent
Hemocleanse, Inc.
2700 Kent Ave.
West Lafayette,  IN  47906
Correspondent Contact STEPHEN R ASH
Regulation Number876.5870
Classification Product Code
FLD  
Date Received12/22/1998
Decision Date 08/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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