Surgi-Tek Tube Positioner
FDA 510(k) K863279 · Dermacare Products, Inc.
510(k) numberK863279
Submission
- Device name
- Surgi-Tek Tube Positioner
- Applicant
- Dermacare Products, Inc.
Louisville, KT, US - Received
- August 25, 1986
- Decision date
- September 9, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Dermacare Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K882494 | Elan-E Disposalbe DrapeKKX · Traditional | 07/08/1988SE |
| K882421 | Infant Electrosurgical Dispersive ElectrodeJOS · Traditional | 06/30/1988SE |
| K871910 | Surgitek Disposable Bipolar CordGEI · Traditional | 06/01/1987SE |
| K863280 | DermamarkerFZZ · Traditional | 09/09/1986SE |
| K863278 | Surgi-Wipes · Traditional | 09/02/1986SE |
| K862367 | Pro-Clean · Traditional | 07/08/1986SE |
| K853374 | Correct-A-Count · Traditional | 09/05/1985SE |
Questions and answers
When was Surgi-Tek Tube Positioner cleared by the FDA?
Surgi-Tek Tube Positioner (K863279) received a 510(k) decision of Substantially Equivalent on September 9, 1986, 15 days after the submission was received.