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510(k) K090803

HANSON MEDICAL FACIAL IMPLANTS by Hanson Medical, Inc. — Product Code FZE

K090803 is an FDA 510(k) premarket notification submitted by Hanson Medical, Inc. for the device "HANSON MEDICAL FACIAL IMPLANTS". The FDA issued a decision of Substantially Equivalent on June 30, 2010. The device falls under product code FZE (Prosthesis, Nose, Internal), a Class II device regulated under 21 CFR 878.3680. Hanson Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2010
Date Received
March 24, 2009
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)
  • K071018 — MONARCH NASAL IMPLANT (May 25, 2007)
  • K041690 — MONARCH NASAL IMPLANT (February 11, 2005)
  • K040307 — HANSON SCAR ADE (August 12, 2004)
  • K030809 — HANSON MEDICAL GLUTEAL IMPLANT (April 21, 2003)
  • K030808 — HANSON MEDICAL CALF IMPLANT (April 21, 2003)
  • K973730 — DURASIL I AND DURASIL II (December 24, 1997)
  • K973729 — POWERFLEX PEC IMPLANT (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)
  • K090630 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) (June 2, 2009)
  • K071018 — MONARCH NASAL IMPLANT (May 25, 2007)
  • K041690 — MONARCH NASAL IMPLANT (February 11, 2005)
  • 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)

FDA data resources