510(k) K152641

Pi Drive Plus Motor, Extender by Stryker Corporation — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2015
Date Received
September 15, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type