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510(k) K914016

ZARA ZONE IV MALAR IMPLANT by Byron Medical — Product Code LZK

K914016 is an FDA 510(k) premarket notification submitted by Byron Medical for the device "ZARA ZONE IV MALAR IMPLANT". The FDA issued a decision of Substantially Equivalent on December 5, 1991. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Byron Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1991
Date Received
September 9, 1991
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 Byron Medical

  • K040149 — PSI-TEC PERISTALTIC INFILTRATION PUMP (June 3, 2004)
  • K001803 — ACCELERATOR RECIPROCATING CANNULA (August 4, 2000)
  • K981215 — PSI-TEC LIPOSUCTION ASPIRATOR (July 1, 1998)
  • K981172 — LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES (June 30, 1998)
  • K980738 — PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILT (June 16, 1998)
  • K980392 — PSI-TEC ASPIRATOR (March 5, 1998)
  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973133 — BIG BAG 3000 PRESSURE INFUSOR (September 12, 1997)
  • K934179 — DISPOSABLE BAG DECANTER (May 23, 1994)
  • K934233 — ZARA ZONE IV MALAR IMPLANT MODIFICATION (February 3, 1994)

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)
  • K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (March 3, 1998)
  • K980140 — SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (March 3, 1998)
  • K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT (March 3, 1998)
  • K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (November 7, 1997)

FDA data resources