The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Assert Self-contained Biological Indicator.
Device ID | K200126 |
510k Number | K200126 |
Device Name: | VERIFY Assert Self-Contained Biological Indicator |
Classification | Indicator, Biological Sterilization Process |
Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | Anthony Piotrkowski |
Correspondent | Anthony Piotrkowski STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Product Code | FRC |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-01-21 |
Decision Date | 2020-05-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10724995153035 | K200126 | 000 |
10724995153028 | K200126 | 000 |
10724995153011 | K200126 | 000 |