Lens Set, Mentor Trial
FDA 510(k) K770389 · Codman & Shurtleff, Inc.
510(k) numberK770389
Submission
- Device name
- Lens Set, Mentor Trial
- Applicant
- Codman & Shurtleff, Inc.
Mchenry, IL, US - Received
- February 28, 1977
- Decision date
- March 14, 1977
- 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 |
| K873907 | Confirmation TestsHPC · Traditional | Richmond Products, Inc. | 12/29/1987SE |
| K852056 | Acc Cross CylindersHPC · Traditional | Ascon Medical Instruments, Ltd. | 06/05/1985SE |
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Questions and answers
When was Lens Set, Mentor Trial cleared by the FDA?
Lens Set, Mentor Trial (K770389) received a 510(k) decision of Substantially Equivalent on March 14, 1977, 14 days after the submission was received.
What is the product code of K770389?
The FDA product code is HPC – Set, Lens, Trial, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1405.