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FDA 510(k) Application Details - K143492
Device Classification Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
More FDA Info for this Device
510(K) Number
K143492
Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant
Bien-Air Surgery SA
Rue de l'Ouest 2b
Le Noirmont 2340 CH
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Contact
Judith Clerc
Other 510(k) Applications for this Contact
Regulation Number
874.4250
More FDA Info for this Regulation Number
Classification Product Code
ERL
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More FDA Info for this Product Code
Date Received
12/08/2014
Decision Date
03/04/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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