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510(k) K101826

Device
HYDROFIX VASO SHIELD, MODEL HVS-001-0610
Applicant
MIMEDX GROUP, INC
510(k) number
K101826
Product code
OMR  
Decision
Se - With Limitations (SESU)
Decision date
2010-07-28
Date received
2010-07-01
Regulation
870.3470
Classification name
Vessel Guard Or Cover
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SALLY THORSEN
Address
811 Livingston Ct. SE Suite B Marietta GA US 30067 30067

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OMR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111048SYNTHES SCOUT TACK FIXATIONSynthes Spine2012-06-14
K111137HYDROFIX VASO SHIELDMimedx Group, Inc.2011-05-20
K101805HYDROFIX VASO SHIELDMimedx Group, Inc.2011-04-08
K103558SYNTHES SCOUT VESSEL GUARDSynthes Spine2011-02-18
K100984XYLOS VESSEL GUARDXylos Corporation2010-07-07
K100905HYDROFIX SURGICAL SHEETMimedx Group, Inc.2010-06-02
K093551PARADIS VASO SHIELDSpinemedica, LLC2009-12-24
K090022PARADIS VASO SHIELDSpinemedica, LLC2009-04-20
K082782REPLICATION MEDICAL VESSEL GUARDReplication Medical, Inc.2009-04-02

Legacy Summary#

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FDA Review#

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