The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Medtronic Transportation / Sterilization Cassettes.
Device ID | K190840 |
510k Number | K190840 |
Device Name: | Medtronic Transportation / Sterilization Cassettes |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132 |
Contact | Elizabeth Hamilton |
Correspondent | Elizabeth Hamilton Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-01 |
Decision Date | 2019-10-15 |