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510(k) K973574

DURALASTIC ANATOMICAL MALAR IMPLANT by Hanson Medical, Inc. — Product Code LZK

K973574 is an FDA 510(k) premarket notification submitted by Hanson Medical, Inc. for the device "DURALASTIC ANATOMICAL MALAR IMPLANT". The FDA issued a decision of Substantially Equivalent on October 24, 1997. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Hanson Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1997
Date Received
September 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Malar
Device Class
Class II
Regulation Number
878.3550
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)
  • 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)

Other clearances for product code LZK

  • K021419 — AART MALAR IMPLANT (July 2, 2002)
  • K002886 — IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) (November 24, 2000)
  • K992240 — PILLAR MALAR IMPLANT (November 22, 1999)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K982763 — SEARE BIOMEDICAL MALAR IMPLANTS (September 30, 1998)
  • K981835 — SILIMED MALAR IMPLANT (July 9, 1998)
  • K980140 — SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (March 3, 1998)
  • K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT (March 3, 1998)
  • K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (March 3, 1998)
  • K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (November 7, 1997)

FDA data resources