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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- HPZImplant, Eye Sphere2Product Code
- K212741EZYPOR2Cleared 510(K)
- K123764DURETTE OCULAR IMPLANT2Cleared 510(K)
- K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEX2Cleared 510(K)
- K112176SILICONE SPHERES2Cleared 510(K)
- K083342ORBITAL RECONSTRUCTIVE IMPLANT II2Cleared 510(K)
- K082850EYE SPHERES2Cleared 510(K)
- K073293DURETTE IMPLANT2Cleared 510(K)
- K071335MEDPOR ATTRACTOR IMPLANT2Cleared 510(K)
- K070130ORBITAL RECONSTRUCTIVE IMPLANT2Cleared 510(K)
- K053298ALPHASPHERE ORBITAL IMPLANT2Cleared 510(K)
Show All 39 Submissions
- HQHEye, Artificial, Non-Custom1Product Code
- HQJImplant, Absorbable, (Scleral Buckling Methods)2Product Code
- HQLIntraocular Lens3Product Code
- HQMKeratoprosthesis, Permanent Implant2Product Code
- HQNConformer, Ophthalmic2Product Code
- HQTShell, Scleral2Product Code
- HQWClip, Tantalum, Ophthalmic2Product Code
- HQXImplant, Orbital, Extra-Ocular2Product Code
- KYFImplant, Eye Valve2Product Code
- MFKLens, Multifocal Intraocular3Product Code
- MJPLens, Intraocular, Toric Optics3Product Code
- MLPKeratoprosthesis, Temporary Implant, Surgical Use2Product Code
- MQUOcular Peg2Product Code
- MTZWrap, Implant, Orbital2Product Code
- NAALens, Intraocular, Accommodative3Product Code
- NCKButton, Iris, Eye, Artificial1Product Code
- NFMExpander, Tissue, Orbital2Product Code
- NIZLens, Iris Reconstruction3Product Code
- NQBConformer, Ophthalmic, Biological Tissue2Product Code
- NXMProsthesis, Eyelid Spacer/Graft, Biologic2Product Code
- POEExtended Depth Of Focus Intraocular Lens3Product Code
- PUFOcular Peg, Exempt2Product Code
- PZKLight Adjustable Lens (Lal) And Light Delivery Device (Ldd)3Product Code
- QCBPhakic Toric Intraocular Lens3Product Code
- QWUProsthesis, Eyelid Spacer/Graft, Polymer2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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SILICONE SPHERES
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K112176
- 510(k) Type
- Special
- Applicant
- OCULO PLASTIK, INC.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/15/2011
- Days to Decision
- 49 days
- Submission Type
- Summary