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FDA 510(k) Application Details - K024076
Device Classification Name
Dialyzer Reprocessing System
More FDA Info for this Device
510(K) Number
K024076
Device Name
Dialyzer Reprocessing System
Applicant
HDC MAQUINOLAS, LLC
8508 BEACON BEND LN.
PEARLAND, TX 77584 US
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Contact
LORI K HOLDER
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LIF
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More FDA Info for this Product Code
Date Received
12/10/2002
Decision Date
09/26/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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