Venneto
FDA 510(k) K974045 · Amsure Sports, Inc.
510(k) numberK974045
Submission
- Device name
- Venneto
- Applicant
- Amsure Sports, Inc.
Honolulu, HI, US - Received
- October 24, 1997
- Decision date
- November 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K973934 | SunglassesHQY · Traditional | Elegance Optical Manufactory, Ltd. | 11/18/1997SE |
| K973526 | SunglassesHQY · Traditional | Pyramid Handbags, Inc. | 10/16/1997SE |
Questions and answers
When was Venneto cleared by the FDA?
Venneto (K974045) received a 510(k) decision of Substantially Equivalent on November 20, 1997, 27 days after the submission was received.
What is the product code of K974045?
The FDA product code is HQY – Sunglasses (Non-Prescription Including Photosensitive), a Class I (low risk) device regulated under 21 CFR 886.5850.