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FDA 510(k) Applications Submitted by ADELE SHOUSTAL
FDA 510(k) Number
Submission Date
Device Name
Applicant
K061710
06/19/2006
CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS
ST. JUDE MEDICAL
K103343
11/15/2010
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
BIONESS INC.
K183177
11/16/2018
Nitinol Thermocouple (TCN) Electrode
Boston Scientific Corporation
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