Exeter Bone Lauage System
FDA 510(k) K790811 · Howmedica Corp.
510(k) numberK790811
Submission
- Device name
- Exeter Bone Lauage System
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- April 26, 1979
- Decision date
- July 30, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FQH – Lavage, Jet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5475
- Specialty
- General Hospital
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| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Exeter Bone Lauage System cleared by the FDA?
Exeter Bone Lauage System (K790811) received a 510(k) decision of Substantially Equivalent on July 30, 1979, 95 days after the submission was received.
What is the product code of K790811?
The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.