The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Stearothermohilus Spore Strips.
| Device ID | K800482 |
| 510k Number | K800482 |
| Device Name: | STEAROTHERMOHILUS SPORE STRIPS |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | MDT CORP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-04 |
| Decision Date | 1980-04-16 |