Spectacle Frame - Lorraine
FDA 510(k) K871689 · Roseburg SA
510(k) numberK871689
Submission
- Device name
- Spectacle Frame - Lorraine
- Applicant
- Roseburg SA
Washington, DC, US - Received
- April 29, 1987
- Decision date
- May 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQZ – Frame, Spectacle
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5842
- Specialty
- Ophthalmic
Other 510(k)s with product code HQZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952597 | View Point, Dorion, Ruddy Project, Ultra Flex, Trillon, Bay Boy, Shield Ski, Sun…HQZ · Traditional | Point of View Optical Outlet, Inc. | 09/12/1995SE |
| K944313 | Spectacle FrameHQZ · Traditional | Sun Hing Optical Manufactory , Ltd. | 03/28/1995SE |
| K945770 | Optical FramesHQZ · Traditional | Ramada Optics, Inc. | 12/15/1994SE |
| K945392 | Spectacle FrameHQZ · Traditional | Seo Han Corp., Ltd. | 12/15/1994SE |
| K945176 | Spectacle Frame or Eyeglass FramesHQZ · Traditional | Optipia Trading Co. | 12/15/1994SE |
| K945350 | Frame, SpectaclesHQZ · Traditional | Taiwan Eva Industrial Co., Inc. | 12/13/1994SE |
| K945342 | MAG-1 Spectacle FrameHQZ · Traditional | Criss Optical Mfg. Co., Inc. | 11/28/1994SE |
| K945450 | Frame, SpectacleHQZ · Traditional | Kookje Apis Industrial Co. | 11/22/1994SE |
| K945340 | Spectacle Frames or Eyeglass FramesHQZ · Traditional | Mi Mun Corp. | 11/22/1994SE |
| K945323 | Spectacle FrameHQZ · Traditional | M.Y. Vision Corp. | 11/22/1994SE |
More from M.Y. Vision Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K931155 | Staple, Fixation Bone; Screw Fixation BoneHWC · Traditional | 09/01/1994SE |
| K890081 | Calius-Isabel Canovas SunglassesHQY · Traditional | 03/09/1989SE |
| K885275 | Assenat-Bleschet SunglassesHQY · Traditional | 01/24/1989SE |
| K882392 | Burnet Laboratoire Pharmaceutique Surgical GlovesKGO · Traditional | 08/26/1988SE |
| K872715 | Universal Instrumentation(Cd) for Spinal SurgeryJDN · Traditional | 12/07/1987SN |
| K874317 | Poirier Kid-Roller Manual WheelchairIOR · Traditional | 11/17/1987SE |
| K872714 | S.T.A.C.E.M. External Breast Prosthesis MammaryGBI · Traditional | 07/21/1987SE |
| K871688 | Spectacle Frame - DanielleHQZ · Traditional | 05/29/1987SE |
| K870654 | Efer ArthroscopeHRX · Traditional | 05/14/1987SE |
| K864436 | Stavip 3000JJN · Traditional | 03/16/1987SE |
Questions and answers
When was Spectacle Frame - Lorraine cleared by the FDA?
Spectacle Frame - Lorraine (K871689) received a 510(k) decision of Substantially Equivalent on May 29, 1987, 30 days after the submission was received.
What is the product code of K871689?
The FDA product code is HQZ – Frame, Spectacle, a Class I (low risk) device regulated under 21 CFR 886.5842.