The following data is part of a premarket notification filed by Steris Corporation with the FDA for Reliance Family Of Washer-disinfectors.
Device ID | K983068 |
510k Number | K983068 |
Device Name: | RELIANCE FAMILY OF WASHER-DISINFECTORS |
Classification | Device, Pasteurization, Hot Water |
Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | Raymond Ursick |
Correspondent | Raymond Ursick STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Product Code | LDS |
CFR Regulation Number | 880.6991 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-02 |
Decision Date | 2000-05-31 |
Summary: | summary |