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510(k) K984162

BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE by Nobelpharma USA, Inc. — Product Code MAH

K984162 is an FDA 510(k) premarket notification submitted by Nobelpharma USA, Inc. for the device "BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE". The FDA issued a decision of Substantially Equivalent on June 28, 1999. The device falls under product code MAH (Hearing Aid, Bone Conduction, Implanted), a Class II device regulated under 21 CFR 874.3302. Nobelpharma USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1999
Date Received
November 19, 1998
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 Nobelpharma USA, Inc.

  • K962403 — NOBLEPHARMA WIDE ACCESSORIES (September 6, 1996)
  • K955713 — NOBELPHARMA BONE ANCHORED HEARING AID (August 9, 1996)
  • K962130 — BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE (July 22, 1996)
  • K961736 — 17 ANGULATED ABUTMENT (July 18, 1996)
  • K961728 — MIRUSCONE ABUTMENT SYSTEM (July 10, 1996)
  • K961737 — CERA ONE ABUTMENT SYSTEM (July 10, 1996)
  • K960639 — ABUTMENT SELECTION KIT (May 14, 1996)
  • K955697 — ABUTMENT RETRIEVAL KIT (January 30, 1996)
  • K955372 — BALL ATTACHMENT SYSTEM (January 23, 1996)
  • K953435 — BRANEMARK RADIOGRAPHIC DEPTH GUAGE (October 3, 1995)

Other clearances for product code MAH

  • K203807 — Ponto Bone Anchored Hearing System, MONO Surgery Kit (March 3, 2021)
  • 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)
  • K080363 — BAHA CORDELLE II (April 10, 2008)

FDA data resources