Mask, Vapor, Monomer
FDA 510(k) K770690 · Howmedica Corp.
510(k) numberK770690
Submission
- Device name
- Mask, Vapor, Monomer
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- April 13, 1977
- Decision date
- July 21, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDY – Evacuator, Vapor, Cement Monomer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4220
- Specialty
- Orthopedic
Other 510(k)s with product code JDY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K902167 | Contain(Tm) Laser Plume FilterJDY · Traditional | Arbor Technologies, Inc. | 01/04/1991SE |
| K902056 | Laser Trap 100 Laser Plume Smoke Evacuation FilterJDY · Traditional | Hollister, Inc. | 10/30/1990SE |
| K862509 | Charcoal Laser Smoke Filter Catalog No. 901103-000JDY · Traditional | Lifestream Int'L, Inc. | 07/23/1986SE |
| K810542 | Cement Fume Evacuator Tank & FilterJDY · Traditional | Walgen Medical Innoventions | 03/13/1981SE |
| K790877 | Biovac: Lfa Laser Fume (Smoke) EvacuatioJDY · Traditional | Stackhouse Assoc. | 05/23/1979SE |
| K780202 | Monomer Evacuation SystemJDY · Traditional | Medishield, Inc. | 02/21/1978SE |
| K760906 | Monomer Vapor Containment SystemJDY · Traditional | Howmedica Corp. | 11/11/1976SE |
More from Howmedica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
| K984202 | Howmedica Humeral Intercalary SystemHSD · Traditional | 02/05/1999SE |
| K984305 | Zeta Multizone Locking Nail SystemHSB · Traditional | 02/01/1999SE |
| 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 Mask, Vapor, Monomer cleared by the FDA?
Mask, Vapor, Monomer (K770690) received a 510(k) decision of Substantially Equivalent on July 21, 1977, 99 days after the submission was received.
What is the product code of K770690?
The FDA product code is JDY – Evacuator, Vapor, Cement Monomer, a Class I (low risk) device regulated under 21 CFR 888.4220.