The following data is part of a premarket notification filed by Minnesota Mining And Mfg. Co. with the FDA for 3m Comply 1248 Gas Plasma Chemical Indicator.
| Device ID | K013228 |
| 510k Number | K013228 |
| Device Name: | 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | MINNESOTA MINING AND MFG. CO. 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 |
| Contact | Tierney Norsted |
| Correspondent | Tierney Norsted MINNESOTA MINING AND MFG. CO. 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-27 |
| Decision Date | 2002-01-18 |
| Summary: | summary |