The following data is part of a premarket notification filed by Steris Corporation with the FDA for Reliance Advance Endoscope Processing System.
Device ID | K123768 |
510k Number | K123768 |
Device Name: | RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM |
Classification | Accessories, Germicide, Cleaning, For Endoscopes |
Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | Marcia L Benedict |
Correspondent | Marcia L Benedict STERIS Corporation 5960 Heisley Road 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 | 2012-12-07 |
Decision Date | 2013-07-26 |
Summary: | summary |