The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Sterilcontainer S2 System.
| Device ID | K193582 |
| 510k Number | K193582 |
| Device Name: | SterilContainer S2 System |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Sierra Mertz |
| Correspondent | Sierra Mertz Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-03-17 |