The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Vh2o2 Indicator Tape.
Device ID | K172753 |
510k Number | K172753 |
Device Name: | VERIFY VH2O2 Indicator Tape |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | Steris Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | Bill Brodbeck |
Correspondent | Bill Brodbeck Steris Corporation 5960 Heisley Road Mentor, OH 44060 |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-12 |
Decision Date | 2018-02-09 |
Summary: | summary |