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FDA 510(k) Application Details - K974426
Device Classification Name
Dialyzer Reprocessing System
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510(K) Number
K974426
Device Name
Dialyzer Reprocessing System
Applicant
REPROCESSING PRODUCTS CORP.
8662 COMSTOCK LN.
MAPLE GROVE, MN 55311 US
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Contact
WALTER B JANSEN
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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
10/27/1997
Decision Date
02/10/1999
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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