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510(k) K090720

COCHLEAR BAHA BP100 by Cochlear Bone Anchored Systems AB — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2009
Date Received
March 18, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Bone Conduction
Device Class
Class II
Regulation Number
874.3302
Review Panel
EN
Submission Type

Other clearances by Cochlear Bone Anchored Systems AB

  • K080363 — BAHA CORDELLE II (April 10, 2008)

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