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FDA 510(k) Application Details - K061515
Device Classification Name
System, Dialysate Delivery, Semi-Automatic, Peritoneal
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510(K) Number
K061515
Device Name
System, Dialysate Delivery, Semi-Automatic, Peritoneal
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN RD
MCGAW PARK, IL 60085 US
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Contact
DAVID E CURTIN
Other 510(k) Applications for this Contact
Regulation Number
876.5630
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Classification Product Code
KPF
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More FDA Info for this Product Code
Date Received
06/01/2006
Decision Date
09/11/2006
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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