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510(k) K211490

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 by Stryker Corporation — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2021
Date Received
May 13, 2021
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

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