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FDA 510(k) Applications Submitted by EDWARD WADDELL
FDA 510(k) Number
Submission Date
Device Name
Applicant
K980619
02/18/1998
SABRATEK PATIENT HOME MANAGEMENT SYSTEM
SABRATEK CORP.
K111073
04/18/2011
SURGIVISION INC. CLEARPOINT SYSTEM
SURGI-VISION, INC.
K102101
07/27/2010
SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
SURGIVISION, INC.
K081881
07/02/2008
GISH TUBING AND CONNECTORS WITH HA COATING
GISH BIOMEDICAL, INC.
K123605
11/21/2012
SMARTFLOW CATHETER
MRI INTERVENTIONS, INC.
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