The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Comply Hydrogen Peroxide Chemical Indicator.
| Device ID | K183211 |
| 510k Number | K183211 |
| Device Name: | 3M Comply Hydrogen Peroxide Chemical Indicator |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | 3M Company 3M Center, Building 275-5W-06 St. Paul, MN 55144 |
| Contact | Nadia Battah |
| Correspondent | Nadia Battah 3M Company 3M Center, Building 275-5W-06 St. Paul, MN 55144 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-02-26 |
| Summary: | summary |