NLD Implant Set
FDA 510(k) K813314 · Design Research Assoc., Inc.
510(k) numberK813314
Submission
- Device name
- NLD Implant Set
- Applicant
- Design Research Assoc., Inc.
Mchenry, IL, US - Received
- November 24, 1981
- Decision date
- February 24, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMX – Cannula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HMX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010305 | Weiss Retinal CannulaHMX · Traditional | Micron Surgical, Inc. | 05/02/2001SE |
| K000457 | Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic…HMX · Traditional | Retinalabs.Com | 05/09/2000SE |
| K970873 | Endosoft Soft Tip Needle (20 Ga. and 19 Ga.)HMX · Traditional | American Medical Devices, Inc. | 05/20/1997SE |
| K943932 | Steriseal Ophthalmic CannulaHMX · Traditional | Pharma-Plast, Ltd. | 01/18/1995SE |
| K942403 | Infusion CannulaHMX · Traditional | Microsurgical Technology, Inc. | 08/17/1994SE |
| K934844 | Inter Tip THMX · Traditional | Microsurgical Technology, Inc. | 04/19/1994SE |
| K930113 | Kirwan Irrigation/Aspiration HandpieceHMX · Traditional | Kirwan Surgical Products, Inc. | 02/17/1994SE |
| K921488 | Aspirating Endo Ocular Probe W/IlluminationHMX · Traditional | Surgical Technologies, Inc. | 05/07/1992SE |
| K915074 | Irrigator/Aspirator ProbeHMX · Traditional | Biomedical Dynamics, Inc. | 02/05/1992SE |
| K904074 | Vitreoretinal Infusion CannulaHMX · Traditional | Visitec Co. | 02/26/1991SE |
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Questions and answers
When was NLD Implant Set cleared by the FDA?
NLD Implant Set (K813314) received a 510(k) decision of Substantially Equivalent on February 24, 1982, 92 days after the submission was received.
What is the product code of K813314?
The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.