The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Mis Attachments And Cutting Accessories.
Device ID | K143540 |
510k Number | K143540 |
Device Name: | Stryker MIS Attachments And Cutting Accessories |
Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
Applicant | STRYKER CORPORATION 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
Contact | Mairead Twomey |
Correspondent | Mairead Twomey STRYKER CORPORATION 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
Product Code | HBE |
CFR Regulation Number | 882.4310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-15 |
Decision Date | 2015-05-01 |
Summary: | summary |