Laser Trap 100 Laser Plume Smoke Evacuation Filter
FDA 510(k) K902056 · Hollister, Inc.
510(k) numberK902056
Submission
- Device name
- Laser Trap 100 Laser Plume Smoke Evacuation Filter
- Applicant
- Hollister, Inc.
Chicago, IL, US - Received
- May 7, 1990
- Decision date
- October 30, 1990
- 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 |
| 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 |
| K770690 | Mask, Vapor, MonomerJDY · Traditional | Howmedica Corp. | 07/21/1977SE |
| K760906 | Monomer Vapor Containment SystemJDY · Traditional | Howmedica Corp. | 11/11/1976SE |
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Questions and answers
When was Laser Trap 100 Laser Plume Smoke Evacuation Filter cleared by the FDA?
Laser Trap 100 Laser Plume Smoke Evacuation Filter (K902056) received a 510(k) decision of Substantially Equivalent on October 30, 1990, 176 days after the submission was received.
What is the product code of K902056?
The FDA product code is JDY – Evacuator, Vapor, Cement Monomer, a Class I (low risk) device regulated under 21 CFR 888.4220.