The following data is part of a premarket notification filed by Best Sanitizers, Inc. with the FDA for Acecide High-level Disinfectant And Sterilant.
| Device ID | K041984 |
| 510k Number | K041984 |
| Device Name: | ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT |
| Classification | Sterilant, Medical Devices |
| Applicant | BEST SANITIZERS, INC. 14605 28TH AVENUE NORTH Minneapolis, MN 55428 |
| Contact | Richard M Ormsbee |
| Correspondent | Richard M Ormsbee BEST SANITIZERS, INC. 14605 28TH AVENUE NORTH Minneapolis, MN 55428 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-23 |
| Decision Date | 2005-05-11 |
| Summary: | summary |