The following data is part of a premarket notification filed by Andersen Sterilizers, Inc. with the FDA for Eogas 4 Endo-steritest Rrbi.
| Device ID | K202879 |
| 510k Number | K202879 |
| Device Name: | EOGas 4 Endo-SteriTest RRBI |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | Andersen Sterilizers, Inc. 3154 Caroline Drive Haw River, NC 27258 |
| Contact | William K. Andersen |
| Correspondent | William K. Andersen Andersen Sterilizers, Inc. 3154 Caroline Drive Haw River, NC 27258 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-28 |
| Decision Date | 2021-03-03 |