The following data is part of a premarket notification filed by Mesa Laboratories, Inc. with the FDA for Sterrad Cyclesure 24 Plus Biological Indicator.
| Device ID | K140589 |
| 510k Number | K140589 |
| Device Name: | STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | MESA LABORATORIES, INC. 8607 PARK DRIVE Omaha, NE 68127 |
| Contact | Kurt Mccauley |
| Correspondent | Kurt Mccauley MESA LABORATORIES, INC. 8607 PARK DRIVE Omaha, NE 68127 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-07 |
| Decision Date | 2014-12-03 |