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510(k) K221184

ORiGO System by Bien-Air Surgery SA — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2022
Date Received
April 25, 2022
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

Other clearances by Bien-Air Surgery SA

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  • K083720 — OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K (March 20, 2009)

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