Monomer Evacuation System
FDA 510(k) K780202 · Medishield, Inc.
510(k) numberK780202
Submission
- Device name
- Monomer Evacuation System
- Applicant
- Medishield, Inc.
Mchenry, IL, US - Received
- February 7, 1978
- Decision date
- February 21, 1978
- 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 |
| K770690 | Mask, Vapor, MonomerJDY · Traditional | Howmedica Corp. | 07/21/1977SE |
| K760906 | Monomer Vapor Containment SystemJDY · Traditional | Howmedica Corp. | 11/11/1976SE |
More from Howmedica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K781103 | SpectrascanDAT · Traditional | 09/27/1978SE |
| K780645 | HMD-2000 Battery-Powered Mini-Drill, theKIJ · Traditional | 05/03/1978SE |
| K780646 | Air-Pwoered ColdrillEKX · Traditional | 04/28/1978SE |
| K770161 | Microfenestrated Hip Replacement Compon.JDG · Traditional | 01/26/1977SE |
| K761021 | Ankle Instruments (Freeman-Swanson)HSN · Traditional | 11/23/1976SE |
| K761020 | Ankle (Freeman-Swanson)HSN · Traditional | 11/23/1976SE |
| K760668 | Selectatec SystemCAD · Traditional | 09/27/1976SE |
Questions and answers
When was Monomer Evacuation System cleared by the FDA?
Monomer Evacuation System (K780202) received a 510(k) decision of Substantially Equivalent on February 21, 1978, 14 days after the submission was received.
What is the product code of K780202?
The FDA product code is JDY – Evacuator, Vapor, Cement Monomer, a Class I (low risk) device regulated under 21 CFR 888.4220.