Omed Dispos. Instrument Guards
FDA 510(k) K842603 · Omega-Med Intl., Inc.
510(k) numberK842603
Submission
- Device name
- Omed Dispos. Instrument Guards
- Applicant
- Omega-Med Intl., Inc.
Mchenry, IL, US - Received
- July 5, 1984
- Decision date
- September 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Omega-Med Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K832441 | Suture-Aid BootiesKDC · Traditional | 03/05/1984SE |
| K830484 | Omed Ident-I-Band · Traditional | 03/24/1983SE |
| K822284 | Comply Neuromuscular StimulatorIPF · Traditional | 09/17/1982SE |
| K821334 | Omed Fabric Instrument Covers-Radiopaq · Traditional | 05/24/1982SE |
| K813499 | Omed Disposable BulldogDXC · Traditional | 12/29/1981SE |
| K810883 | Omed Silicone Instrument CoversKDC · Traditional | 04/23/1981SE |
| K810269 | Omed Fabric Instrument CoversKDC · Traditional | 02/26/1981SE |
| K810260 | Omed Silicone LoopsKDC · Traditional | 02/26/1981SE |
Questions and answers
When was Omed Dispos. Instrument Guards cleared by the FDA?
Omed Dispos. Instrument Guards (K842603) received a 510(k) decision of Substantially Equivalent on September 5, 1984, 62 days after the submission was received.