The following data is part of a premarket notification filed by Aesculap, Inc with the FDA for Sterilcontainer S System.
| Device ID | K162815 |
| 510k Number | K162815 |
| Device Name: | SterilContainer S System |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | AESCULAP, INC 3773 CORPORATE PKWY Center Valley, PA 18034 |
| Contact | Paul Amudala |
| Correspondent | Paul Amudala AESCULAP, INC 3773 CORPORATE PKWY 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 | 2016-10-06 |
| Decision Date | 2017-07-13 |
| Summary: | summary |