Custom Procedure Kit (Various Sub-Titles)
FDA 510(k) K861198 · Quali-Med, Inc.
510(k) numberK861198
Submission
- Device name
- Custom Procedure Kit (Various Sub-Titles)
- Applicant
- Quali-Med, Inc.
Sugar Land, TX, US - Received
- March 31, 1986
- Decision date
- May 16, 1986
- Decision
- Unknown (SESD)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Quali-Med, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871408 | Blood Vessel Connector · Traditional | 04/27/1987SE |
| K862972 | Disposable Mirror · Traditional | 09/23/1986SE |
| K862472 | Quartz Rods Titanium RodsGEX · Traditional | 09/12/1986SE |
| K862241 | Standard Basin Kit Custom Basin KitFRG · Traditional | 08/01/1986SE |
| K862242 | Pap Smear KitHHT · Traditional | 06/26/1986SE |
| K862172 | Quali-Med's Operating Room DrapesKKX · Traditional | 06/19/1986SE |
Questions and answers
When was Custom Procedure Kit (Various Sub-Titles) cleared by the FDA?
Custom Procedure Kit (Various Sub-Titles) (K861198) received a 510(k) decision of Unknown on May 16, 1986, 46 days after the submission was received.