The following data is part of a premarket notification filed by Thompson Surgical Instruments with the FDA for Mis Spine Frame Instrument Case.
Device ID | K151347 |
510k Number | K151347 |
Device Name: | MIS Spine Frame Instrument Case |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | THOMPSON SURGICAL INSTRUMENTS 10170 E CHERRY BEND RD Traverse City, MI 49684 |
Contact | Stephanie Myers |
Correspondent | Stephanie Myers THOMPSON SURGICAL INSTRUMENTS 10170 E CHERRY BEND RD Traverse City, MI 49684 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-20 |
Decision Date | 2015-10-16 |
Summary: | summary |