The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify V24 Self-contained Biological Indicator.
Device ID | K140708 |
510k Number | K140708 |
Device Name: | VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR |
Classification | Indicator, Biological Sterilization Process |
Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | Bill Brodeck |
Correspondent | Bill Brodeck 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 | 2014-03-21 |
Decision Date | 2014-06-16 |
Summary: | summary |