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510(k) K143492

OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece by Bien-Air Surgery SA — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2015
Date Received
December 8, 2014
Clearance Type
Traditional
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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