510(k) K904921
- Device
- STERI-VAC(TM) AERATOR MODEL XL
- Applicant
- 3M HEALTH CARE, LTD.
- 510(k) number
- K904921
- Product code
- FLI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-12-05
- Date received
- 1990-10-31
- Regulation
- 880.6100
- Classification name
- Cabinet, Ethylene-oxide Gas Aerator
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARVIN L HART
- Address
- 3m Center, Bldg. 275-3e-08 P.O. Box 33275 St. Paul MN US 55133 55133
FDA Registration Numbers#
- 3042272797
- 3031841433
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FLI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K902906 | GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR | Gas-Vak | 1990-10-15 |
| K831595 | CASTLE MODEL 3341 & 3441 & 4141 GAS AER | Castle Co. | 1983-06-15 |
| K830165 | BEAR JET 150 VENTILATOR | Bear Medical Systems, Inc. | 1983-04-12 |
| K813201 | CASTLE #3241 GAS AERATOR | Sybron Corp. | 1981-12-31 |
| K790677 | EO EVACUATING SYSTEM I | Castle Co. | 1979-05-07 |
| K781484 | CASTLE MODEL 3146 GAS AERATOR | Castle Co. | 1978-10-27 |
| K761341 | PORTAGAS AERATOR | Amsco Co. | 1977-02-28 |
Legacy Summary#
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FDA Review#
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