The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Jj Series Container System.
Device ID | K192056 |
510k Number | K192056 |
Device Name: | JJ Series Container 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 | 2019-08-01 |
Decision Date | 2020-03-27 |