POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT— 510(k) K863946
Substantially EquivalentPorex Medical
FDA 510(k) clearance K863946 for POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT, Substantially Equivalent on 1987-02-27. Applicant: Porex Medical. Device class: 2.
Clearance details
- Applicant
- Porex Medical
- Product code
- Code HQX
- Device class
- Class 2
- Regulation
- 21 CFR 886.3340
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fairburn, GA, US
Recent devices under product code HQX
view all- K023481 — MICROVISION SCLERAL BUCKLING COMPONENTS
- K983581 — OCU-GUARD AND OCU-GUARD SUPPLE
- K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
- K963219 — RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES
- K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
More clearances from Porex Medical
view allData sourced from openFDA. This site is unofficial and independent of the FDA.