Argyle Enternal Feeding Bag W/Admin
FDA 510(k) K840877 · Sherwood Medical Co.
510(k) numberK840877
Submission
- Device name
- Argyle Enternal Feeding Bag W/Admin
- Applicant
- Sherwood Medical Co.
Mchenry, IL, US - Received
- February 27, 1984
- Decision date
- June 28, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFS – Shield, Nipple
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5630
- Specialty
- General Hospital
Other 510(k)s with product code HFS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944177 | Breast ShellHFS · Traditional | O'Donnell, Byrne & Williams | 10/05/1994SE |
| K944117 | Avent Nipple ShieldHFS · Traditional | Avent America, Inc. | 10/05/1994SE |
| K935341 | Comfort Plus Breast ShellsHFS · Traditional | Marshall Baby Products | 01/21/1994SE |
| K935340 | Comfort Plus Nipple ShieldsHFS · Traditional | Marshall Baby Products | 01/21/1994SE |
| K930238 | Breast Leakage Inhibitor System: Breast ShieldsHFS · Traditional | Prolac, Inc. | 08/16/1993SE |
| K923577 | Breast ShellsHFS · Traditional | Medela, Inc. | 01/22/1993SE |
| K864176 | Gentle FeelHFS · Traditional | Mali, Inc. | 11/04/1986SE |
| K861608 | Unicare Breast ShellsHFS · Traditional | Unicare Medical Products, Inc. | 07/15/1986SE |
| K853176 | Cannon Babysafe Nipple ShieldsHFS · Traditional | Medela, Inc. | 08/22/1985SE |
| K833450 | Nuk Breast ShieldHFS · Traditional | Reliance Products Corp. | 11/21/1983SE |
More from Reliance Products Corp.
| 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 Argyle Enternal Feeding Bag W/Admin cleared by the FDA?
Argyle Enternal Feeding Bag W/Admin (K840877) received a 510(k) decision of Substantially Equivalent on June 28, 1984, 122 days after the submission was received.
What is the product code of K840877?
The FDA product code is HFS – Shield, Nipple, a Class I (low risk) device regulated under 21 CFR 880.5630.