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510(k) K902284

ZYMALAR IMPLANT by Applied Biomaterial Technologies — Product Code LZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1990
Date Received
May 22, 1990
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 Applied Biomaterial Technologies

  • K935571 — DURALASTIC SHEETING (January 31, 1995)
  • K945552 — DURALASTIC SHEETING (January 31, 1995)
  • K931500 — THE PERMARIDGE MATRIX CHIN (November 17, 1994)
  • K913768 — PEC IMPLANT (February 3, 1992)
  • K902285 — THE MAGNUM CHIN IMPLANT (September 12, 1990)
  • K902283 — THE NAUTILUS NASAL IMPLANT (August 14, 1990)

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)