The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Attest Vaporized Hydrogen Peroxide Tri-metric Chemical Indicator 1348/1348e.
| Device ID | K193110 |
| 510k Number | K193110 |
| Device Name: | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E |
| Classification | A Chemical Vapor Sterilization Multivariable Chemical Indicator |
| Applicant | 3M Health Care 2510 Conway Avenue, Bldg. 275-5W-06 St. Paul, MN 55144 -1000 |
| Contact | Andrew Wingen |
| Correspondent | Andrew Wingen 3M Health Care 2510 Conway Avenue, Bldg. 275-5W-06 St. Paul, MN 55144 -1000 |
| Product Code | QKM |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-12 |
| Decision Date | 2020-03-13 |