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510(k) K041690

MONARCH NASAL IMPLANT by Hanson Medical, Inc. — Product Code FZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2005
Date Received
June 22, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Nose, Internal
Device Class
Class II
Regulation Number
878.3680
Review Panel
SU
Submission Type

Other clearances by Hanson Medical, Inc.

  • K141822 — SENSEI X ROBOTIC CATHETER SYSTEM (August 5, 2014)
  • K090803 — HANSON MEDICAL FACIAL IMPLANTS (June 30, 2010)
  • K071018 — MONARCH NASAL IMPLANT (May 25, 2007)
  • K040307 — HANSON SCAR ADE (August 12, 2004)
  • K030808 — HANSON MEDICAL CALF IMPLANT (April 21, 2003)
  • K030809 — HANSON MEDICAL GLUTEAL IMPLANT (April 21, 2003)
  • K973729 — POWERFLEX PEC IMPLANT (December 24, 1997)
  • K973730 — DURASIL I AND DURASIL II (December 24, 1997)
  • K973573 — DURALASTIC ANATOMICAL NASAL IMPLANTS (November 13, 1997)
  • K973728 — SILICONE CARVING BLOCK (November 13, 1997)

Other clearances for product code FZE

  • K241253 — Medicon Epiplating System (December 12, 2024)
  • K161548 — Osseointegrated Fixtures (December 1, 2016)
  • K090803 — HANSON MEDICAL FACIAL IMPLANTS (June 30, 2010)
  • K090630 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) (June 2, 2009)
  • K071018 — MONARCH NASAL IMPLANT (May 25, 2007)
  • K021418 — AART NASAL IMPLANT (July 2, 2002)
  • K992242 — PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (November 22, 1999)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K982753 — SEARE BIOMEDICAL NASAL IMPLANTS (September 30, 1998)
  • K981833 — SILIMED NASAL L SHAPED IMPLANT (June 26, 1998)