The following data is part of a premarket notification filed by Steris with the FDA for Reliance Eps Endoscope Processing System And Reliance Dg Dry Germicide.
Device ID | K203223 |
510k Number | K203223 |
Device Name: | Reliance EPS Endoscope Processing System And Reliance DG Dry Germicide |
Classification | Accessories, Germicide, Cleaning, For Endoscopes |
Applicant | STERIS 5960 Heisley Rd Mentor, OH 44060 |
Contact | Marcia L. Benedict |
Correspondent | Marcia L. Benedict STERIS 5960 Heisley Rd Mentor, OH 44060 |
Product Code | NZA |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-02 |
Decision Date | 2021-01-28 |