Steri-Vac(Tm) Aerator Model XL
FDA 510(k) K904921 · 3M Health Care, Ltd.
510(k) numberK904921
Submission
- Device name
- Steri-Vac(Tm) Aerator Model XL
- Applicant
- 3M Health Care, Ltd.
St. Paul, MN, US - Received
- October 31, 1990
- Decision date
- December 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FLI – Cabinet, Ethylene-Oxide Gas Aerator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6100
- Specialty
- General Hospital
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| K813201 | Castle #3241 Gas AeratorFLI · Traditional | Sybron Corp. | 12/31/1981SE |
| K790677 | Eo Evacuating System IFLI · Traditional | Castle Co. | 05/07/1979SE |
| K781484 | Castle Model 3146 Gas AeratorFLI · Traditional | Castle Co. | 10/27/1978SE |
| K761341 | Portagas AeratorFLI · Traditional | Amsco Co. | 02/28/1977SE |
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Questions and answers
When was Steri-Vac(Tm) Aerator Model XL cleared by the FDA?
Steri-Vac(Tm) Aerator Model XL (K904921) received a 510(k) decision of Substantially Equivalent on December 5, 1990, 35 days after the submission was received.
What is the product code of K904921?
The FDA product code is FLI – Cabinet, Ethylene-Oxide Gas Aerator, a Class II (moderate risk) device regulated under 21 CFR 880.6100.