Confirmation Tests
FDA 510(k) K873907 · Richmond Products, Inc.
510(k) numberK873907
Submission
- Device name
- Confirmation Tests
- Applicant
- Richmond Products, Inc.
Boca Raton, FL, US - Received
- September 25, 1987
- Decision date
- December 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPC – Set, Lens, Trial, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1405
- Specialty
- Ophthalmic
Other 510(k)s with product code HPC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945443 | Bobes Lens SetHPC · Traditional | Bobes S.A. | 07/19/1995SE |
| K951437 | Oti Model TLS-60HPC · Traditional | Oti Medical, LLC | 04/11/1995SE |
| K930195 | Ophthalmic Trial LensesHPC · Traditional | Optimark Accessories and Instruments | 01/06/1994SE |
| K934859 | Contact LensesHPC · Traditional | Arno Intl., Inc. | 12/21/1993SE |
| K930446 | Marco Trial SetsHPC · Traditional | Marco Ophthalmic, Inc. | 07/06/1993SE |
| K924786 | Burton Trial Lens SetHPC · Traditional | R.H. Burton Co. | 04/14/1993SE |
| K920571 | Trial Lens SetHPC · Traditional | R.H. Burton Co. | 05/07/1992SE |
| K900478 | Woodlyn Full Aperture Trial Lens SetHPC · Traditional | Woodlyn, Inc. | 02/21/1990SE |
| K852056 | Acc Cross CylindersHPC · Traditional | Ascon Medical Instruments, Ltd. | 06/05/1985SE |
| K843095 | Tria Lens SetHPC · Traditional | Optek Medico Co., Ltd. | 10/05/1984SE |
More from Optek Medico Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K874252 | Kreda DiscHOQ · Traditional | 01/27/1988SE |
| K874251 | Worth 4 Dot Test Distance C/W Muscle LightHLP · Traditional | 01/11/1988SE |
| K874250 | Three Char. Test-Child & Worth 4 Dot Test Nearpt.HLP · Traditional | 01/11/1988SE |
| K873908 | H.R.R. Pseudoisochromatic Color Blindness Test Bk.HIT · Traditional | 12/23/1987SE |
| K873916 | 'E' Cube and 'E' PadHOX · Traditional | 12/11/1987SE |
| K873914 | Animated Fixation Toys (Distance and Nearpoint)HPL · Traditional | 12/11/1987SE |
| K873913 | Color Book Illuminator StandHJD · Traditional | 12/02/1987SE |
| K873911 | Pseudo Isochromatic Color Blindness Test Book - 15HIT · Traditional | 12/02/1987SE |
| K873917 | Tonometer TapesHKX · Traditional | 11/02/1987SE |
| K873912 | Richmond Visual Field ScreenerHOO · Traditional | 11/02/1987SE |
Questions and answers
When was Confirmation Tests cleared by the FDA?
Confirmation Tests (K873907) received a 510(k) decision of Substantially Equivalent on December 29, 1987, 95 days after the submission was received.
What is the product code of K873907?
The FDA product code is HPC – Set, Lens, Trial, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1405.