The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Hpu Chemical Indicator/ Verify Vaporized Vh202 Process Indicator Adhesive Label.
| Device ID | K140515 |
| 510k Number | K140515 |
| Device Name: | VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-28 |
| Decision Date | 2014-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995001848 | K140515 | 000 |