The following data is part of a premarket notification filed by Steris Corporation with the FDA for The Reliance Endoscope Processing System.
Device ID | K040049 |
510k Number | K040049 |
Device Name: | THE RELIANCE ENDOSCOPE PROCESSING SYSTEM |
Classification | Accessories, Germicide, Cleaning, For Endoscopes |
Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | Nancy A Robinson |
Correspondent | Nancy A Robinson 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 | 2004-01-12 |
Decision Date | 2004-12-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00724995152178 | K040049 | 000 |
00724995193676 | K040049 | 000 |
00724995193683 | K040049 | 000 |
00724995193690 | K040049 | 000 |
00724995193706 | K040049 | 000 |
50724995083774 | K040049 | 000 |
04961333243044 | K040049 | 000 |
04961333243051 | K040049 | 000 |
00724995000639 | K040049 | 000 |
00724995001544 | K040049 | 000 |
00724995001551 | K040049 | 000 |
00724995087883 | K040049 | 000 |
00724995087890 | K040049 | 000 |
00724995087906 | K040049 | 000 |
00724995087913 | K040049 | 000 |
00724995087920 | K040049 | 000 |
00724995090630 | K040049 | 000 |
00724995193669 | K040049 | 000 |