510(k) K023481
- Device
- MICROVISION SCLERAL BUCKLING COMPONENTS
- Applicant
- MICROVISION, INC.
- 510(k) number
- K023481
- Product code
- HQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-08
- Date received
- 2002-10-17
- Regulation
- 886.3340
- Classification name
- Implant, Orbital, Extra-ocular
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHEILA HEMEON-HEYER, JD, RAC
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
FDA Registration Numbers#
- 1218813
- 3002991496
- 1226011
- 9615745
- 3009337401
- 1220477
- 3002807090
- 3004467263
- 9611516
- 3005941719
- 2031962
- 1000286794
- 3010162973
Source Documents#
Other 510(k) Records For Product Code HQX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Bio-Vascular, Inc. | 1998-11-06 |
| K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | Fci Ophthalmics, Inc. | 1998-09-18 |
| K963219 | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES | Fci Ophthalmics, Inc. | 1996-10-28 |
| K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | Mira, Inc. | 1996-06-05 |
| K950599 | STORS SCLERAL SPONGE II (LINCOFF DESIGN) | Storz Ophthalmics, Inc. | 1995-03-02 |
| K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | Visitec Co. | 1995-01-17 |
| K902308 | TAMCENAN OCULAR EXPLANTS AND BANDS | Tamcenan Corp. | 1990-06-19 |
| K901002 | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES | Oculo Plastik, Inc. | 1990-05-22 |
| K900929 | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL | Oculo Plastik, Inc. | 1990-05-18 |
| K900927 | CODERE-DURETTE ORBITAL FLOOR IMPLANT | Oculo Plastik, Inc. | 1990-05-15 |
| K900928 | COX MALAR EMINENCE IMPLANTS | Oculo Plastik, Inc. | 1990-05-15 |
| K900930 | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT | Oculo Plastik, Inc. | 1990-05-15 |
| K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | Porex Medical | 1987-02-27 |
| K832481 | SCLERAL BUCKLING IMPLANTS DIF/TYPES | Storz Instrument Co. | 1983-09-20 |
| K800140 | SILASTIC SCLERAL SPONGE II W/CIRCLING BD | Dow Corning Corp. Healthcare Industries Materials | 1980-03-03 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases