The following data is part of a premarket notification filed by Serim Research Corporation with the FDA for Wavicide-opa Mec Indicator.
| Device ID | K202565 |
| 510k Number | K202565 |
| Device Name: | WAVICIDE-OPA MEC Indicator |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | Serim Research Corporation 3506 Reedy Drive Elkhart, IN 46514 |
| Contact | Jackie Nelson |
| Correspondent | Jackie Nelson Serim Research Corporation 3506 Reedy Drive Elkhart, IN 46514 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-04 |
| Decision Date | 2020-12-02 |