510(k) K190172

Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments by Stryker — Product Code HBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2019
Date Received
February 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device Class
Class II
Regulation Number
882.4310
Review Panel
NE
Submission Type