Cup, Disposable Medicine
FDA 510(k) K760517 · Landmark Plastics
510(k) numberK760517
Submission
- Device name
- Cup, Disposable Medicine
- Applicant
- Landmark Plastics
Walker, MI, US - Received
- August 25, 1976
- Decision date
- November 12, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYX – Dispenser, Liquid Medication
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6430
- Specialty
- General Hospital
Other 510(k)s with product code KYX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143177 | KleenGel DispenserKYX · Traditional | Kleengel, LLC | 09/14/2015SE |
| K980109 | Cyclotech Cyclosporine Oral Solutions DispenserKYX · Traditional | Sangstat Medical Corp. | 08/18/1998SE |
| K954181 | Canyons Bi-Directional Check ValveKYX · Traditional | Canyon Medical Products | 11/29/1995SE |
| K830571 | Bottle AdapterKYX · Traditional | Burron Medical Products, Inc. | 03/24/1983SE |
| K801008 | Multi-Ad Fluid Dispensing Pump MP-3000KYX · Traditional | Burron Medical Products, Inc. | 06/02/1980SE |
| K800437 | Syringe Tip ConnectorKYX · Traditional | Burron Medical Products, Inc. | 03/12/1980SE |
| K800362 | Fluid Dispensing SystemKYX · Traditional | Pharmaseal Laboratories | 03/12/1980SE |
| K792227 | Multi-Ad Fluid Dispensing SystemKYX · Traditional | National Patent Development Corp. | 12/20/1979SE |
| K781364 | Pint Bottle WellKYX · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 10/17/1978SE |
| K771539 | StepperKYX · Traditional | Tridak | 10/07/1977SE |
More from Tridak
| 510(k) | Device | Decision |
|---|---|---|
| K760552 | Thermometer Stand and Dust CoverFLK · Traditional | 11/12/1976SE |
| K760548 | Carafe and Liner · Traditional | 11/12/1976SE |
| K760497 | Tray, ServiceLRP · Traditional | 11/12/1976SE |
| K760496 | Cup, Disposable SpecimenFMH · Traditional | 11/12/1976SE |
| K760495 | Basin, Rectangular WashFNY · Traditional | 11/12/1976SE |
| K760494 | Basin, Round WashFNY · Traditional | 11/12/1976SE |
| K760493 | Dish, Soap · Traditional | 11/12/1976SE |
| K760492 | Basin, Large or SmallFNY · Traditional | 11/12/1976SE |
| K760490 | Bedpan, General Medical Medi-PakFOB · Traditional | 11/12/1976SE |
| K760491 | Tumbler, General Medical Medi-PakLDR · Traditional | 09/15/1976SE |
Questions and answers
When was Cup, Disposable Medicine cleared by the FDA?
Cup, Disposable Medicine (K760517) received a 510(k) decision of Substantially Equivalent on November 12, 1976, 79 days after the submission was received.
What is the product code of K760517?
The FDA product code is KYX – Dispenser, Liquid Medication, a Class I (low risk) device regulated under 21 CFR 880.6430.