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510(k) K083720

OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K by Bien-Air Surgery SA — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2009
Date Received
December 15, 2008
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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