Additive Hinge Cap
FDA 510(k) K791796 · Abbott Laboratories
510(k) numberK791796
Submission
- Device name
- Additive Hinge Cap
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- September 14, 1979
- Decision date
- October 1, 1979
- 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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Questions and answers
When was Additive Hinge Cap cleared by the FDA?
Additive Hinge Cap (K791796) received a 510(k) decision of Substantially Equivalent on October 1, 1979, 17 days after the submission was received.
What is the product code of K791796?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.