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 | K152241 |
510k Number | K152241 |
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 | Victoria Scheitlin |
Correspondent | Victoria Scheitlin 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 | 2015-08-10 |
Decision Date | 2016-01-20 |
Summary: | summary |