Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K012328
Device Classification Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
More FDA Info for this Device
510(K) Number
K012328
Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant
DI-CHEM, INC.
12297 ENSIGN AVE. NORTH
CHAMPLIN, MN 55316 US
Other 510(k) Applications for this Company
Contact
KEITH A BUCHHOLZ
Other 510(k) Applications for this Contact
Regulation Number
876.5820
More FDA Info for this Regulation Number
Classification Product Code
KPO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/2001
Decision Date
01/18/2002
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact