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FDA 510(k) Applications Submitted by DAVID CASAL
FDA 510(k) Number
Submission Date
Device Name
Applicant
K040316
02/09/2004
CEDIA BUPRENORPHINE ASSAY
MICROGENICS CORP.
K040411
02/18/2004
DRI OXYCODONE ASSAY
MICROGENICS CORP.
K040758
03/25/2004
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
MICROGENICS CORP.
K021036
04/01/2002
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
INTUITIVE SURGICAL, INC.
K011002
04/03/2001
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
INTUITIVE SURGICAL, INC.
K041073
04/26/2004
DOCUMENT SALICYLATE CAL VER
MICROGENICS CORP.
K001666
05/31/2000
MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
INTUITIVE SURGICAL, INC.
DEN040008
06/17/2004
CEDIA SIROLIMUS ASSAY
MICROGENICS CORP.
K002489
08/10/2000
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM
INTUITIVE SURGICAL, INC.
K032811
09/09/2003
CEDIA VANCOMYCIN ASSAY
MICROGENICS CORP.
K032842
09/11/2003
MICROGENICS CYCLOSPORINE CONTROL KIT
MICROGENICS CORP.
K974260
11/13/1997
PYRILINKS-D ASSAY KIT
METRA BIOSYSTEMS, INC.
K053524
12/19/2005
C-PORT DISTAL ANASTOMOSIS SYSTEM
CARDICA, INC.
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