Sialography Needle
FDA 510(k) K831666 · Vertex Medical Corp.
510(k) numberK831666
Submission
- Device name
- Sialography Needle
- Applicant
- Vertex Medical Corp.
Mchenry, IL, US - Received
- May 23, 1983
- Decision date
- July 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Vertex Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K833742 | Eschmann Dilation Catheter · Traditional | 04/24/1984SE |
| K834476 | Nephrostomy/Biliary Drainage BagLJE · Traditional | 02/04/1984SE |
| K832380 | Protective SleeveDYG · Traditional | 11/28/1983SE |
| K830576 | Lymphangiography SetDQO · Traditional | 03/17/1983SE |
| K830420 | Polyethylene Monitoring ConnectorsDQO · Traditional | 02/28/1983SE |
| K830237 | Translucent Poly. Cath. Connector andDQO · Traditional | 02/18/1983SE |
| K823340 | Clear Vinyl Monitoring ConnectorDXT · Traditional | 12/30/1982SE |
| K823256 | Ultra-Asept Angiographic Syringe/SpareDXT · Traditional | 12/30/1982SE |
| K823254 | Reusable Metal StopcockDXT · Traditional | 12/30/1982SE |
| K823253 | Vertex Monitoring CatheterDXT · Traditional | 12/30/1982SE |
Questions and answers
When was Sialography Needle cleared by the FDA?
Sialography Needle (K831666) received a 510(k) decision of Substantially Equivalent on July 12, 1983, 50 days after the submission was received.