The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Comply 1228 Gas Plasma Indicator Tape.
| Device ID | K020589 |
| 510k Number | K020589 |
| Device Name: | 3M COMPLY 1228 GAS PLASMA INDICATOR TAPE |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55133 -3275 |
| Contact | Joann L Huehn |
| Correspondent | Joann L Huehn 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55133 -3275 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-22 |
| Decision Date | 2002-04-22 |
| Summary: | summary |