The following data is part of a premarket notification filed by Steritec Products Mfg Co Inc with the FDA for Getinge Assured Mi Steam Migrating Integrator.
| Device ID | K200252 |
| 510k Number | K200252 |
| Device Name: | Getinge Assured MI Steam Migrating Integrator |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SteriTec Products MFG Co Inc 74 Inverness Drive East Englewood, CO 80112 |
| Contact | Jonathan Rutigliano |
| Correspondent | Jonathan Rutigliano SteriTec Products MFG Co Inc 74 Inverness Drive East Englewood, CO 80112 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-03 |
| Decision Date | 2020-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30814434021231 | K200252 | 000 |