FDA 510(k) Applications for Medical Device Product Code "HQX"
(Implant, Orbital, Extra-Ocular)

FDA 510(k) Number Applicant Device Name Decision Date
K983581 BIO-VASCULAR, INC. OCU-GUARD AND OCU-GUARD SUPPLE 11/06/1998
K980816 FCI OPHTHALMICS, INC. RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES 09/18/1998
K963219 FCI OPHTHALMICS, INC. RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES 10/28/1996
K023481 MICROVISION, INC. MICROVISION SCLERAL BUCKLING COMPONENTS 01/08/2003
K950806 MIRA, INC. SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS 06/05/1996


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