Pressurizer, Exeter Cement
FDA 510(k) K781792 · Howmedica Corp.
510(k) numberK781792
Submission
- Device name
- Pressurizer, Exeter Cement
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- October 25, 1978
- Decision date
- February 8, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIZ – Dish, Tissue Culture
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2240
- Specialty
- Hematology
Other 510(k)s with product code KIZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890542 | Multiwell Culture Plate InsertsKIZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/14/1989SE |
| K873891 | Tissue Culture DishesKIZ · Traditional | Nunc, Inc. | 11/25/1987SE |
| K871483 | Tissue Culture/Bacteriological Petri DishesKIZ · Traditional | Isratech Marketing Corp. | 04/29/1987SE |
| K854724 | Cekk-Adhesive Matrix-Multiple Well Plate Cam-PlateKIZ · Traditional | Lifetrac, Inc. | 12/13/1985SE |
| K853634 | Corning Cell Wells-Multiple Well PlatesKIZ · Traditional | Corning Medical & Scientific | 09/16/1985SE |
| K821687 | Removawell Tissue Culture Plate W/LidKIZ · Traditional | Dynatech Corp. | 06/24/1982SE |
| K790958 | 120 Well Histo-PlateKIZ · Traditional | Dynatech Laboratories, Inc. | 06/28/1979SE |
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| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
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| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| 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 Pressurizer, Exeter Cement cleared by the FDA?
Pressurizer, Exeter Cement (K781792) received a 510(k) decision of Substantially Equivalent on February 8, 1979, 106 days after the submission was received.
What is the product code of K781792?
The FDA product code is KIZ – Dish, Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.