Various Sunglasses
FDA 510(k) K923374 · Playtime Products, Inc.
510(k) numberK923374
Submission
- Device name
- Various Sunglasses
- Applicant
- Playtime Products, Inc.
Washington, DC, US - Received
- July 9, 1992
- Decision date
- June 9, 1993
- 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 |
| 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 |
|---|---|---|
| K993794 | Platex Oder Absorbing Gentle Glide, Slimfits and Silk Glide TamponsHEB · Traditional | 02/07/2000SE |
| K981760 | Playtex Silk Glide Odor Absorbing Flushable Cardboard Tampons #13598HEB · Traditional | 07/22/1998SE |
| K964269 | Playtex Tampons Gentle Glide Deordorant Tampons and Playtex/Gentle Glide Deodorant…HIL · Traditional | 11/29/1996SE |
| K961456 | Playtex Tampons #10296HIL · Traditional | 06/18/1996SE |
| K952394 | Playtex Tampons #13695HEB · Traditional | 08/21/1995SE |
| K950928 | Ultimates Silk Glide TamponsHIL · Traditional | 03/22/1995SE |
| K923375 | Playskool SunglassesHQY · Traditional | 06/09/1993SE |
Questions and answers
When was Various Sunglasses cleared by the FDA?
Various Sunglasses (K923374) received a 510(k) decision of Substantially Equivalent on June 9, 1993, 335 days after the submission was received.
What is the product code of K923374?
The FDA product code is HQY – Sunglasses (Non-Prescription Including Photosensitive), a Class I (low risk) device regulated under 21 CFR 886.5850.