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FDA 510(k) Application Details - K033505
Device Classification Name
Dialyzer Reprocessing System
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510(K) Number
K033505
Device Name
Dialyzer Reprocessing System
Applicant
MINNTECH CORP.
14605 28TH AVE. NORTH
MINNEAPOLIS, MN 55447 US
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Contact
RICHARD M ORMSBEE
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
11/05/2003
Decision Date
04/27/2004
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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