Additive Cap (2B8905)
FDA 510(k) K760880 · Travenol Laboratories, S.A.
510(k) numberK760880
Submission
- Device name
- Additive Cap (2B8905)
- Applicant
- Travenol Laboratories, S.A.
Mchenry, IL, US - Received
- October 21, 1976
- Decision date
- December 30, 1976
- 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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| K222622 | Disposable Infusion Bag for Parenteral NutritionKPE · Traditional | Beijing L&Z Medical Technology Development Co.… | 02/16/2023SE |
| K210749 | Empty EVA BagKPE · Traditional | Haemotronic S.P.A. | 08/19/2021SE |
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| K871471 | Capillary Flow Dialyzers Models ST-12 & ST-15FJI · Traditional | 06/12/1987SE |
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Questions and answers
When was Additive Cap (2B8905) cleared by the FDA?
Additive Cap (2B8905) (K760880) received a 510(k) decision of Substantially Equivalent on December 30, 1976, 70 days after the submission was received.
What is the product code of K760880?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.