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 |