Charter Laboratories Inc. Lens Lubricant
FDA 510(k) K863974 · Paco Pharmaceutical Services, Inc.
510(k) numberK863974
Submission
- Device name
- Charter Laboratories Inc. Lens Lubricant
- Applicant
- Paco Pharmaceutical Services, Inc.
Lakewood, NJ, US - Received
- October 14, 1986
- Decision date
- November 10, 1986
- 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 |
| K897021 | Martin-Hensley Segment LensHPX · Traditional | Bruce W. Martin O.D. and Edward Hensley | 06/22/1990SE |
| 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 |
| 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 |
More from Safeway Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K865111 | Charter Hard Contact Lens Cleaning SolutionHPX · Traditional | 01/20/1987SE |
| K862952 | Charter Wetting Solution for Hard Contact LensesHPX · Traditional | 09/25/1986SE |
| K843797 | Sterile Saline SolutionBSY · Traditional | 01/18/1985SE |
| K843796 | Sterile Water · Traditional | 12/10/1984SE |
| K761093 | BandageNAD · Traditional | 01/06/1977SE |
Questions and answers
When was Charter Laboratories Inc. Lens Lubricant cleared by the FDA?
Charter Laboratories Inc. Lens Lubricant (K863974) received a 510(k) decision of Substantially Equivalent on November 10, 1986, 27 days after the submission was received.
What is the product code of K863974?
The FDA product code is HPX – Lens, Contact (Polymethylmethacrylate), a Unclassified device.