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 |