Martin-Hensley Segment Lens
FDA 510(k) K897021 · Bruce W. Martin O.D. and Edward Hensley
510(k) numberK897021
Submission
- Device name
- Martin-Hensley Segment Lens
- Applicant
- Bruce W. Martin O.D. and Edward Hensley
Gladwin, MI, US - Received
- December 19, 1989
- Decision date
- June 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPX – Lens, Contact (Polymethylmethacrylate)
- Device class
- Unclassified
Other 510(k)s with product code HPX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955777 | Pmma ClasicHPX · Traditional | Rand Scientific Corp. | 05/16/1996SE |
| K940106 | Keratoplasty Suturing LensHPX · Traditional | Visionary Technologies of Miami, Inc. | 05/25/1994SE |
| K913081 | Multi-View BifocalsHPX · Traditional | Camp Contact Lenses | 10/23/1991SE |
| K895411 | Optikem Pmma Contact LensHPX · Traditional | Optikem Polymers, Inc. | 02/27/1990SE |
| K874591 | Illuminating Infusion Contact Lens for Eye SurgeryHPX · Traditional | Vitreo Dynamics, Co. | 05/03/1988SE |
| K865111 | Charter Hard Contact Lens Cleaning SolutionHPX · Traditional | Paco Pharmaceutical Services, Inc. | 01/20/1987SE |
| K864343 | BL1 (Hard Contact Lens)HPX · Traditional | Beta Labs, Inc. | 11/28/1986SE |
| K863974 | Charter Laboratories Inc. Lens LubricantHPX · Traditional | Paco Pharmaceutical Services, Inc. | 11/10/1986SE |
| K862952 | Charter Wetting Solution for Hard Contact LensesHPX · Traditional | Paco Pharmaceutical Services, Inc. | 09/25/1986SE |
| K862811 | Aqualux Lens CaseHPX · Traditional | Safeway Products, Inc. | 09/03/1986SE |
Questions and answers
When was Martin-Hensley Segment Lens cleared by the FDA?
Martin-Hensley Segment Lens (K897021) received a 510(k) decision of Substantially Equivalent on June 22, 1990, 185 days after the submission was received.
What is the product code of K897021?
The FDA product code is HPX – Lens, Contact (Polymethylmethacrylate), a Unclassified device.