The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Comply Lead Free Process Indicators For Steam.
| Device ID | K101528 |
| 510k Number | K101528 |
| Device Name: | 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Contact | Suzanne Leung |
| Correspondent | Suzanne Leung 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-02 |
| Decision Date | 2010-10-01 |
| Summary: | summary |