The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Steri-vac(tm) Aerator Model Xl.
| Device ID | K904921 |
| 510k Number | K904921 |
| Device Name: | STERI-VAC(TM) AERATOR MODEL XL |
| Classification | Cabinet, Ethylene-oxide Gas Aerator |
| Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Contact | Marvin L Hart |
| Correspondent | Marvin L Hart 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Product Code | FLI |
| CFR Regulation Number | 880.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-31 |
| Decision Date | 1990-12-05 |