Manual Ophthalmic Surgical Instruments
FDA 510(k) K874963 · Solway, Inc.
510(k) numberK874963
Submission
- Device name
- Manual Ophthalmic Surgical Instruments
- Applicant
- Solway, Inc.
Hollywood, FL, US - Received
- December 2, 1987
- Decision date
- December 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNA – Spud, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931449 | MSP Ophthalmic (Eye Spud)HNA · Traditional | Medical Sterile Products, Inc. | 08/31/1993SE |
More from Medical Sterile Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874960 | Cardiovascular Surgical InstrumentsDWS · Traditional | 02/05/1988SE |
| K874962 | Forceps Cliprack Ventricular Cannula Saws SpatulasHAO · Traditional | 02/02/1988SE |
| K874956 | Self-Retaining Retractor for NeurosurgeryGZT · Traditional | 01/28/1988SE |
| K874964 | Dental Hand InstrumentsEKJ · Traditional | 01/27/1988SE |
| K875043 | Rongeur (Neurosurgical Instruments)HAE · Traditional | 01/22/1988SE |
| K874966 | Tuning ForksGWX · Traditional | 01/04/1988SE |
| K874965 | Manual Surgical Instruments for General UseHTD · Traditional | 12/30/1987SE |
| K874961 | Bone Cutting Instruments & AccessoriesGDR · Traditional | 12/30/1987SE |
| K874959 | Vascular ClampHXD · Traditional | 12/30/1987SE |
| K874954 | Manual RongeurHTX · Traditional | 12/30/1987SE |
Questions and answers
When was Manual Ophthalmic Surgical Instruments cleared by the FDA?
Manual Ophthalmic Surgical Instruments (K874963) received a 510(k) decision of Substantially Equivalent on December 23, 1987, 21 days after the submission was received.
What is the product code of K874963?
The FDA product code is HNA – Spud, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.