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FDA 510(k) Application Details - K971053
Device Classification Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
More FDA Info for this Device
510(K) Number
K971053
Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant
INTERNATIONAL MEDICAL PRODUCTS, INC.
4503 MOORLAND AVE.
MINNEAPOLIS, MN 55435 US
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Contact
JEFFREY R SHIDEMAN
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Regulation Number
876.5820
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Classification Product Code
KPO
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More FDA Info for this Product Code
Date Received
03/24/1997
Decision Date
06/16/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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