The following data is part of a premarket notification filed by Steris Corporation with the FDA for Reliance Endoscope Processing System.
Device ID | K102244 |
510k Number | K102244 |
Device Name: | RELIANCE ENDOSCOPE PROCESSING SYSTEM |
Classification | Accessories, Germicide, Cleaning, For Endoscopes |
Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | Robert F Sullivan |
Correspondent | Robert F Sullivan 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 | 2010-08-09 |
Decision Date | 2010-12-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00724995002619 | K102244 | 000 |
00724995194420 | K102244 | 000 |