Vial Decanter
FDA 510(k) K852893 · Advance Medical Designs, Inc.
510(k) numberK852893
Submission
- Device name
- Vial Decanter
- Applicant
- Advance Medical Designs, Inc.
Marietta, GA, US - Received
- July 9, 1985
- Decision date
- September 20, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KPE – Container, I.V.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5025
- Specialty
- General Hospital
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| K011422 | Surgical DrapesKKX · Traditional | 07/10/2001SE |
| K003670 | Patient Drape, SurgicalKKX · Traditional | 01/26/2001SE |
| K925115 | Amd Dentist and Hygienist KitsEKJ · Traditional | 07/05/1994SE |
| K911884 | Advance Pressure Monitor/High Pressure LinesDTL · Traditional | 07/05/1994SE |
| K915301 | Advance Stopcock/High Pressure StopcockDTL · Traditional | 12/11/1992SE |
Questions and answers
When was Vial Decanter cleared by the FDA?
Vial Decanter (K852893) received a 510(k) decision of Substantially Equivalent on September 20, 1985, 73 days after the submission was received.
What is the product code of K852893?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.