The following data is part of a premarket notification filed by Z-systems Ag with the FDA for St-z5.
| Device ID | K201878 |
| 510k Number | K201878 |
| Device Name: | ST-Z5 |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Z-Systems AG Werkhofstrasse 5 Oensingen, CH Ch-4702 |
| Contact | Rubino Digirolamo |
| Correspondent | Kevin A Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-07 |
| Decision Date | 2021-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640166767893 | K201878 | 000 |
| 07640166761778 | K201878 | 000 |
| 07640166761761 | K201878 | 000 |
| 07640166761754 | K201878 | 000 |
| 07640166761747 | K201878 | 000 |