Argyle Double Seal Chest Drainage Unit
FDA 510(k) K802891 · Sherwood Medical Co.
510(k) numberK802891
Submission
- Device name
- Argyle Double Seal Chest Drainage Unit
- Applicant
- Sherwood Medical Co.
Mchenry, IL, US - Received
- November 17, 1980
- Decision date
- December 19, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1430
- Specialty
- Anesthesiology
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|---|---|---|
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| 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 Argyle Double Seal Chest Drainage Unit cleared by the FDA?
Argyle Double Seal Chest Drainage Unit (K802891) received a 510(k) decision of Substantially Equivalent on December 19, 1980, 32 days after the submission was received.
What is the product code of K802891?
The FDA product code is CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1430.