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FDA 510(k) Application Details - K031676
Device Classification Name
Set, Administration, For Peritoneal Dialysis, Disposable
More FDA Info for this Device
510(K) Number
K031676
Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN RD., MPR-A2E
MCGAW PARK, IL 60085-6730 US
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Contact
DAVID E CURTIN
Other 510(k) Applications for this Contact
Regulation Number
876.5630
More FDA Info for this Regulation Number
Classification Product Code
KDJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/30/2003
Decision Date
11/20/2003
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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