Cristy/Cote
FDA 510(k) K843096 · Titmus Optical, Inc.
510(k) numberK843096
Submission
- Device name
- Cristy/Cote
- Applicant
- Titmus Optical, Inc.
Petersburg, VA, US - Received
- August 7, 1984
- Decision date
- November 21, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQG – Lens, Spectacle, Non-Custom (Prescription)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5844
- Specialty
- Ophthalmic
Other 510(k)s with product code HQG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K935919 | SunglassesHQG · Traditional | Ja-Ru, Inc. | 02/16/1994SE |
| K920795 | 0R 160, OR-1.60, and Orcolite 1.60 High IndexHQG · Traditional | Optical Radiation Corp. | 07/13/1992SE |
| K900091 | Modified Ophthalmic Opir Onufryk Image DeflectorHQG · Traditional | Onufryk Low Vision Ent. | 04/04/1990SE |
| K884360 | Seiko P-6 Progressive Spectacle LensesHQG · Traditional | Seiko Corp. | 11/15/1988SE |
| K882814 | Neolens Prescription Spectacle LensHQG · Traditional | Neolens, Inc. | 07/29/1988SE |
| K882308 | CR-39 Plastic Lenses for EyeglassesHQG · Traditional | Automated Lens System | 07/22/1988SE |
| K881225 | Ophthalmic Spectacle Lens BlanksHQG · Traditional | Beta Optical Co, Inc. | 04/19/1988SE |
| K875063 | Seiko Plax Diacoat II & Seiko Plax S.V.P.HQG · Traditional | Epson EL Paso, Inc. | 02/22/1988SE |
| K874681 | Swirl - a Pre-Moistened Cleaning Tissue for EyesHQG · Traditional | Klockner Contract Packaging, Inc. | 02/05/1988SE |
| K873245 | Ar Diacoat Single Vision LensesHQG · Traditional | Seiko Optical Products of America, Inc. | 10/05/1987SE |
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Questions and answers
When was Cristy/Cote cleared by the FDA?
Cristy/Cote (K843096) received a 510(k) decision of Substantially Equivalent on November 21, 1984, 106 days after the submission was received.
What is the product code of K843096?
The FDA product code is HQG – Lens, Spectacle, Non-Custom (Prescription), a Class I (low risk) device regulated under 21 CFR 886.5844.