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FDA 510(k) Applications Submitted by DAVID J COLLETTE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K121912
07/02/2012
E1 EAR SENSORS
MASIMO CORPORATION
K121914
07/02/2012
MASIMO SET USPO2 PULSE OXIMETRY CABLE
MASIMO CORPORATION
K102769
09/24/2010
NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S
K113596
12/05/2011
MASIMO SET REUSABLE OXIMETRY SENSORS
MASIMO CORPORATION
K110561
02/28/2011
FORTROSS BONE VOID FILLER
PIONEER SURGICAL TECHNOLOGY
K100698
03/11/2010
STCC
CARDINAL SPINE, LLC
K091031
04/10/2009
PIONEER SURGICAL NANOSS BVF-E
PIONEER SURGICAL TECHNOLOGY
K071743
06/27/2007
PILLAR PEDICLE SCREW SYSTEM
THE 4TH COLUMN, LLC
K071796
07/02/2007
CAPSEW PLICATION SYSTEM
CAYENNE MEDICAL, INC.
K082058
07/21/2008
DYNAMATRIX
COOK BIOTECH, INC.
K103084
10/19/2010
NEODENT GRAFT SCREW
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S
K073054
10/30/2007
MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER
CAYENNE MEDICAL, INC.
K083858
12/24/2008
BOND BONE
AUGMA BIOMATERIALS, LTD.
K073685
12/28/2007
OTA COLLAGEN BIOMATERIAL
OSSEOUS TECHNOLOGIES OF AMERICA
K100361
02/12/2010
NANOSS BONE VOID FILLER
PIONEER SURGICAL TECHNOLOGY
K110965
04/06/2011
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC
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