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FDA 510(k) Application Details - K992196
Device Classification Name
Apparatus, Hemoperfusion, Sorbent
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510(K) Number
K992196
Device Name
Apparatus, Hemoperfusion, Sorbent
Applicant
HEMOCLEANSE, INC.
2700 KENT AVE.
WEST LAFAYETTE, IN 47906 US
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Contact
STEPHEN R ASH
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Regulation Number
876.5870
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Classification Product Code
FLD
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More FDA Info for this Product Code
Date Received
06/30/1999
Decision Date
09/10/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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