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510(k) K182116

BA310 Abutment, BIA310 Implant/Abutment by Cochlear Americas — Product Code MAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2018
Date Received
August 6, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K112053 — OBC BONE ANCHORED HEARING SYSTEM (November 18, 2011)
  • K080363 — BAHA CORDELLE II (April 10, 2008)
  • K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (June 28, 1999)