Calius-Isabel Canovas Sunglasses
FDA 510(k) K890081 · Roseburg SA
510(k) numberK890081
Submission
- Device name
- Calius-Isabel Canovas Sunglasses
- Applicant
- Roseburg SA
Washington, DC, US - Received
- January 10, 1989
- Decision date
- March 9, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQY – Sunglasses (Non-Prescription Including Photosensitive)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5850
- Specialty
- Ophthalmic
Other 510(k)s with product code HQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974860 | Non-Prescription SunglassesHQY · Traditional | Wenzhou Ming Ming Optical Co. , Ltd. | 01/30/1998SE |
| K974852 | Non-Prescription SunglassesHQY · Traditional | Chia Hui Spectacles Mfg. Corp. | 01/30/1998SE |
| K974861 | Non-Prescription SunglassesHQY · Traditional | Wenzhou Hindar Optical Co., Ltd. | 01/27/1998SE |
| K974511 | SunglassesHQY · Traditional | Sun World Intl., Inc. | 01/12/1998SE |
| K974441 | SunglassesHQY · Traditional | Hip Shing Fat Co., Ltd. | 01/09/1998SE |
| K974414 | MultiHQY · Traditional | Morning Calm Corp. | 12/08/1997SE |
| K973528 | SunglassesHQY · Traditional | Jeou Jeou Long Industrial Co., Ltd. | 12/08/1997SE |
| K974179 | Non-Prescription SunglassesHQY · Traditional | Taipan Optical Company , Ltd. | 12/01/1997SE |
| K974045 | VennetoHQY · Traditional | Amsure Sports, Inc. | 11/20/1997SE |
| K973934 | SunglassesHQY · Traditional | Elegance Optical Manufactory, Ltd. | 11/18/1997SE |
More from Elegance Optical Manufactory, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K931155 | Staple, Fixation Bone; Screw Fixation BoneHWC · Traditional | 09/01/1994SE |
| 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 |
| K871689 | Spectacle Frame - LorraineHQZ · Traditional | 05/29/1987SE |
| 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 Calius-Isabel Canovas Sunglasses cleared by the FDA?
Calius-Isabel Canovas Sunglasses (K890081) received a 510(k) decision of Substantially Equivalent on March 9, 1989, 58 days after the submission was received.
What is the product code of K890081?
The FDA product code is HQY – Sunglasses (Non-Prescription Including Photosensitive), a Class I (low risk) device regulated under 21 CFR 886.5850.