Amcon Slip in Mydriatic Sunglasses
FDA 510(k) K942407 · Amcon Laboratories, Inc.
510(k) numberK942407
Submission
- Device name
- Amcon Slip in Mydriatic Sunglasses
- Applicant
- Amcon Laboratories, Inc.
Issaquah, WA, US - Received
- May 20, 1994
- Decision date
- June 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HOY – Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4750
- Specialty
- Ophthalmic
Other 510(k)s with product code HOY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132042 | AMB101 System, Amblyz, LCG System, XpandHOY · Traditional | X6d, Ltd. | 04/28/2014SE |
| K050856 | LCG (Liquide Crystal Glasses) SystemHOY · Traditional | Ophthocare , Ltd. | 05/31/2005SE |
| K971465 | National Medical Halthcare Custom Ophthalmic Kits or TraysHOY · Traditional | National Healthcare Mfg. Corp. | 06/04/1997SE |
| K944700 | Arctic Premier SeriesHOY · Traditional | Sungold Eyewear, Inc. | 12/22/1994SE |
| K944857 | Goggle SafeguardHOY · Traditional | Sellstrom Mfg. Co. | 12/15/1994SE |
| K945351 | Shield, Eye, OphthalmicHOY · Traditional | Taiwan Eva Industrial Co., Inc. | 12/13/1994SE |
| K945346 | Makrolon 2405 Goggles (Light and Dark)HOY · Traditional | Universal Massage & Tanning, Inc. | 11/22/1994SE |
| K941829 | Sun Filters/ShieldsHOY · Traditional | Klinger Eye Shields, Inc. | 05/17/1994SE |
| K930347 | Shaids Protective GlassesHOY · Traditional | Depuy, Inc. | 04/29/1994SE |
| K940275 | Universal Cushioned Polycarbonat Eye ShieldHOY · Traditional | P.J. Products, Inc. | 03/24/1994SE |
Questions and answers
When was Amcon Slip in Mydriatic Sunglasses cleared by the FDA?
Amcon Slip in Mydriatic Sunglasses (K942407) received a 510(k) decision of Substantially Equivalent on June 6, 1994, 17 days after the submission was received.
What is the product code of K942407?
The FDA product code is HOY – Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear), a Class I (low risk) device regulated under 21 CFR 886.4750.