The following data is part of a premarket notification filed by Steris Corporation with the FDA for Reliance Endoscope Processing System.
Device ID | K200989 |
510k Number | K200989 |
Device Name: | Reliance Endoscope Processing System |
Classification | Accessories, Germicide, Cleaning, For Endoscopes |
Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | Jennifer Nalepka |
Correspondent | Jennifer Nalepka STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Product Code | NZA |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-15 |
Decision Date | 2020-05-14 |