Sep-T-Vac Suction Cannister W/ Tubing
FDA 510(k) K790379 · Sherwood Medical Co.
510(k) numberK790379
Submission
- Device name
- Sep-T-Vac Suction Cannister W/ Tubing
- Applicant
- Sherwood Medical Co.
Mchenry, IL, US - Received
- February 23, 1979
- Decision date
- April 10, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDQ – Bottle, Collection, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
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More from Davol, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981365 | Mahurkar 13.5 FR Cuffed Catheter with Curved ExtensionsMSD · Traditional | 11/25/1998SE |
| K960982 | Monoject Blunt I.V. Access Cannula/Monoject Hypodermic Syringe with Blunt I.V. Access…FMI · Traditional | 12/23/1996SE |
| K962880 | Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery SystemCAZ · Traditional | 12/09/1996SESK |
| K960574 | Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter…FHO · Traditional | 08/05/1996SE |
| K960677 | Kangaroo Jejunal Feeding SystemKNT · Traditional | 05/13/1996SE |
| K960632 | Kangaroo Feeding Tube Placment StyletKNT · Traditional | 05/09/1996SE |
| K955831 | Argyle Aspr-Care Closed Suction SystemBSY · Traditional | 03/28/1996SE |
| K954429 | Kangaroo Entristar Skin-Level Gastrostomy KitKNT · Traditional | 03/08/1996SESK |
| K954525 | Sensi-Touch Epidural Anesthesia FilterBXN · Traditional | 01/19/1996SE |
| K950201 | Argyle(R) Hydrophilic Coated Thoracic CatheterJOL · Traditional | 12/15/1995SE |
Questions and answers
When was Sep-T-Vac Suction Cannister W/ Tubing cleared by the FDA?
Sep-T-Vac Suction Cannister W/ Tubing (K790379) received a 510(k) decision of Substantially Equivalent on April 10, 1979, 46 days after the submission was received.
What is the product code of K790379?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.