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510(k) K982763

SEARE BIOMEDICAL MALAR IMPLANTS by Seare Biomedical Corp. — Product Code LZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1998
Date Received
August 6, 1998
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 Seare Biomedical Corp.

  • K983630 — SEARE BIOMEDICAL SILICONE RODS (December 11, 1998)
  • K983792 — SEARE BIOMEDICAL SILICONE TISSUE EXPANDER (December 11, 1998)
  • K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT (September 30, 1998)
  • K983043 — SEARE BIOMEDICAL SILICONE BLOCK (September 30, 1998)
  • K982753 — SEARE BIOMEDICAL NASAL IMPLANTS (September 30, 1998)
  • K982752 — SEARE BIOMEDICAL CHIN IMPLANTS (September 30, 1998)
  • K983041 — SEARE BIOMEDICAL SILICONE SHEETING (September 30, 1998)

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)
  • 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)
  • K973574 — DURALASTIC ANATOMICAL MALAR IMPLANT (October 24, 1997)