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510(k) K002586

Device
MEDPOR PTERIONAL SURGICAL IMPLANT
Applicant
POREX SURGICAL PRODUCTS GROUP
510(k) number
K002586
Product code
MNF  
Decision
Substantially Equivalent (SESE)
Decision date
2000-11-17
Date received
2000-08-21
Regulation
878.3550
Classification name
Implant, Temporal
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
HOWARD MERCER
Address
15 Dart Rd. Newnan GA US 30265 30265

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MNF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111069OSTEOSYMBIONICS, ST TEMPORALIS IMPLANTOsteosymbionics, LLC2011-09-22

Legacy Summary#

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FDA Review#

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