The following data is part of a premarket notification filed by Revolutionary Science with the FDA for Saniclave 250.
| Device ID | K180272 |
| 510k Number | K180272 |
| Device Name: | Saniclave 250 |
| Classification | Sterilizer, Steam |
| Applicant | REVOLUTIONARY SCIENCE 17319 Lake Blvd Shafer, MN 55074 |
| Contact | Isaac Erickson |
| Correspondent | Isaac Erickson REVOLUTIONARY SCIENCE 17319 Lake Blvd Shafer, MN 55074 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-31 |
| Decision Date | 2018-07-26 |
| Summary: | summary |