The following data is part of a premarket notification filed by Steris Corporation with the FDA for Micro-mec 1.8% Glutaraldehyde Monitor Strip.
| Device ID | K172472 |
| 510k Number | K172472 |
| Device Name: | Micro-MEC 1.8% Glutaraldehyde Monitor Strip |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Jennifer Nalepka |
| Correspondent | Jennifer Nalepka 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 | 2017-08-15 |
| Decision Date | 2017-11-17 |
| Summary: | summary |