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FDA 510(k) Applications Submitted by CARBOMEDICS, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K960169
01/16/1996
CARBOMEDICS VALVE TESTER
CARBOMEDICS, INC.
K960923
03/06/1996
CARBOMEDICS MITRAL ROTATOR
CARBOMEDICS, INC.
K955588
12/07/1995
VASCUTEK GRAFT SIZER SET
CARBOMEDICS, INC.
K962154
06/04/1996
CARBOMEDICS HANDLE
CARBOMEDICS, INC.
K970375
02/03/1997
ANNULOFLO SYSTEM
CARBOMEDICS, INC.
K960706
02/21/1996
VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
CARBOMEDICS, INC.
K964665
11/21/1996
VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
CARBOMEDICS, INC.
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