Pmma Clasic
FDA 510(k) K955777 · Rand Scientific Corp.
510(k) numberK955777
Submission
- Device name
- Pmma Clasic
- Applicant
- Rand Scientific Corp.
Sacramento, CA, US - Received
- December 20, 1995
- Decision date
- May 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HPX – Lens, Contact (Polymethylmethacrylate)
- Device class
- Unclassified
Other 510(k)s with product code HPX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
More from Safeway Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963856 | Rand Nasal PackingEMX · Traditional | 10/18/1996SE |
| K961081 | Spirit Ridge Silicone Carving BlockMIB · Traditional | 05/22/1996SE |
| K961057 | Duralastic Sheeting IIMIB · Traditional | 05/16/1996SE |
| K961124 | The NautilusFZE · Traditional | 04/19/1996SE |
| K961080 | Medial Malar ImplantLZK · Traditional | 04/19/1996SE |
| K961072 | Pec ImplantMIC · Traditional | 04/19/1996SE |
| K961071 | The Magnum Chin ImplantFWP · Traditional | 04/19/1996SE |
| K955366 | Trans-Aire Rigid Gas Permable Contact LensHQD · Traditional | 03/28/1996SE |
| K952165 | Trans-Aire Rigid Gas Permeable Contact LensHQD · Traditional | 06/30/1995SE |
Questions and answers
When was Pmma Clasic cleared by the FDA?
Pmma Clasic (K955777) received a 510(k) decision of Substantially Equivalent on May 16, 1996, 148 days after the submission was received.
What is the product code of K955777?
The FDA product code is HPX – Lens, Contact (Polymethylmethacrylate), a Unclassified device.