Frame, Spectacle
FDA 510(k) K945450 · Kookje Apis Industrial Co.
510(k) numberK945450
Submission
- Device name
- Frame, Spectacle
- Applicant
- Kookje Apis Industrial Co.
Seoul, KR - Received
- November 3, 1994
- Decision date
- November 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K945340 | Spectacle Frames or Eyeglass FramesHQZ · Traditional | Mi Mun Corp. | 11/22/1994SE |
| K945323 | Spectacle FrameHQZ · Traditional | M.Y. Vision Corp. | 11/22/1994SE |
| K945123 | Aristar Eyewear, Esprit EyewearHQZ · Traditional | Aristar Inc. U.S.A. | 11/22/1994SE |
Questions and answers
When was Frame, Spectacle cleared by the FDA?
Frame, Spectacle (K945450) received a 510(k) decision of Substantially Equivalent on November 22, 1994, 19 days after the submission was received.
What is the product code of K945450?
The FDA product code is HQZ – Frame, Spectacle, a Class I (low risk) device regulated under 21 CFR 886.5842.