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510(k) K080363

BAHA CORDELLE II by Cochlear Bone Anchored Systems AB — Product Code MAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2008
Date Received
February 11, 2008
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

Other clearances by Cochlear Bone Anchored Systems AB

  • K090720 — COCHLEAR BAHA BP100 (June 17, 2009)

Other clearances for product code MAH

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  • K182116 — BA310 Abutment, BIA310 Implant/Abutment (December 19, 2018)
  • K152820 — Ponto Bone Anchored Hearing System (January 22, 2016)
  • K152067 — Ponto bone anchored hearing system (November 23, 2015)
  • K150555 — BA400 14mm Abutment (July 15, 2015)
  • K142678 — Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing (January 21, 2015)
  • K121317 — COCHLEAR BAHA IMPLANT SYSTEM (October 12, 2012)
  • K121228 — PONTO BONE ANCHORED HEARING SYSTEM (September 7, 2012)
  • K112053 — OBC BONE ANCHORED HEARING SYSTEM (November 18, 2011)
  • K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (June 28, 1999)