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510(k) K040689

Device
EYE SPHERE IMPLANTS
Applicant
OCULO PLASTIK, INC.
510(k) number
K040689
Product code
HPZ  
Decision
Substantially Equivalent (SESE)
Decision date
2004-06-10
Date received
2004-03-16
Regulation
886.3320
Classification name
Implant, Eye Sphere
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEAN-FRANCOIS DRETTE
Address
200 Sauve W. Montreal, Quebec CA H3L 1Y9 H3L 1Y9

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HPZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K212741EZYPORFci (France Chirurgie Instrumentation) Sas2022-06-24
K123764DURETTE OCULAR IMPLANTOculo-Plastik, Inc.2013-01-31
K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEXCeramisys, Ltd.2011-11-02
K112176SILICONE SPHERESOculo Plastik, Inc.2011-09-15
K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.2009-03-12
K082850EYE SPHERESProduct and Educational Services, LLC2009-02-27
K073293DURETTE IMPLANTOculo Plastik, Inc.2008-03-19
K071335MEDPOR ATTRACTOR IMPLANTPorex Surgical, Inc.2007-08-08
K070130ORBITAL RECONSTRUCTIVE IMPLANTBecker & Associates Consulting, Inc.2007-04-19
K053298ALPHASPHERE ORBITAL IMPLANTHydron Pty Limited2006-05-09
K040851MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEMPorex Surgical, Inc.2004-07-16
K023400FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANTFci Ophthalmics, Inc.2003-08-22
K021643HA ORBITAL IMPLANTLaboratoire Villanova2002-12-13
K021357MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANTPorex Surgical, Inc.2002-08-05
K010902MEDPOR QUAD MOTILITY IMPLANTPorex Surgical, Inc.2001-06-19

Legacy Summary#

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FDA Review#

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