Tamcenan Ocular Explants and Bands
FDA 510(k) K902308 · Tamcenan Corp.
510(k) numberK902308
Submission
- Device name
- Tamcenan Ocular Explants and Bands
- Applicant
- Tamcenan Corp.
Sioux Falls, SD, US - Received
- May 22, 1990
- Decision date
- June 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQX – Implant, Orbital, Extra-Ocular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3340
- Specialty
- Ophthalmic
- Implant
- Yes
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|---|---|---|---|
| K023481 | Microvision Scleral Buckling ComponentsHQX · Traditional | Microvision, Inc. | 01/08/2003SE |
| K983581 | Ocu-Guard and Ocu-Guard SuppleHQX · Special | Bio-Vascular, Inc. | 11/06/1998SE |
| K980816 | Retinal Detachment Implants, Including Bands, Strips (Rails) and SpongesHQX · Traditional | Fci Ophthalmics, Inc. | 09/18/1998SE |
| K963219 | Retinal Detachment Implants; Including Bans, Strips, Tires, Sleeves, Cords and SpongesHQX · Traditional | Fci Ophthalmics, Inc. | 10/28/1996SE |
| K950806 | Solid Dilicone Implants, Sdilicone Sponge ImplantsHQX · Traditional | Mira, Inc. | 06/05/1996SE |
| K950599 | Stors Scleral Sponge II (Lincoff Design)HQX · Traditional | Storz Ophthalmics, Inc. | 03/02/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | Visitec Co. | 01/17/1995SE |
| K901002 | O'Donnell, Socket Reconstruction ProsthesesHQX · Traditional | Oculo Plastik, Inc. | 05/22/1990SE |
| K900929 | Putterman-Scott, Socket Reconstruction BilateralHQX · Traditional | Oculo Plastik, Inc. | 05/18/1990SE |
| K900930 | Spivey-Allen Orbital Floor ImplantHQX · Traditional | Oculo Plastik, Inc. | 05/15/1990SE |
More from Oculo Plastik, Inc.
Questions and answers
When was Tamcenan Ocular Explants and Bands cleared by the FDA?
Tamcenan Ocular Explants and Bands (K902308) received a 510(k) decision of Substantially Equivalent on June 19, 1990, 28 days after the submission was received.
What is the product code of K902308?
The FDA product code is HQX – Implant, Orbital, Extra-Ocular, a Class II (moderate risk) device regulated under 21 CFR 886.3340.