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FDA 510(k) Applications Submitted by CHRIS SCAVOTTO
FDA 510(k) Number
Submission Date
Device Name
Applicant
K060008
01/03/2006
AQUADEX FLEXFLOW SYSTEM
CHF SOLUTIONS, INC.
K070512
02/22/2007
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
CHF SOLUTIONS, INC.
K050609
03/10/2005
AQUADEX SYSTEM
CHF SOLUTIONS, INC.
K190910
04/08/2019
PrisMax System Version 2
Baxter Healthcare Corp
K071854
07/05/2007
AQUADEX FLEXFLOW SYSTEM
CHF SOLUTIONS, INC.
K062922
09/28/2006
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
CHF SOLUTIONS, INC.
K163530
12/16/2016
PrisMax Control Unit
BAXTER HEALTHCARE CORP
K193482
12/17/2019
PrisMax System Version 3
Baxter Healthcare Corporation
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