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FDA 510(k) Applications Submitted by LEIGH AYRES
FDA 510(k) Number
Submission Date
Device Name
Applicant
K080069
01/10/2008
DIMERTEST
AMERICAN DIAGNOSTICA, INC.
K161052
04/14/2016
OsteoFab Patient Specific Facial Device
OXFORD PERFORMANCE MATERIALS, INC.
K121818
06/20/2012
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
OXFORD PERFORMANCE MATERIALS
K142005
07/23/2014
SpineFab Vertebral Body Replacement (VBR) System
OXFORD PERFORMANCE MATERIALS
K052124
08/05/2005
ACTICLOT, MODEL 824
AMERICAN DIAGNOSTICA, INC.
K133809
12/16/2013
OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
OXFORD PERFORMANCE MATERIALS
K033457
10/30/2003
M2 COMPATIBLE MICROKERATOME BLADE
MICRO SPECIALTIES, INC.
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