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510(k) K955713

NOBELPHARMA BONE ANCHORED HEARING AID by Nobelpharma USA, Inc. — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1996
Date Received
December 18, 1995
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 Nobelpharma USA, Inc.

  • K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (June 28, 1999)
  • K962403 — NOBLEPHARMA WIDE ACCESSORIES (September 6, 1996)
  • K962130 — BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE (July 22, 1996)
  • K961736 — 17 ANGULATED ABUTMENT (July 18, 1996)
  • K961737 — CERA ONE ABUTMENT SYSTEM (July 10, 1996)
  • K961728 — MIRUSCONE 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)

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