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510(k) K971479

DURALASTIC ANATOMICAL MALAR IMPLANTS by Allied Biomedical Corp. — Product Code LZK

K971479 is an FDA 510(k) premarket notification submitted by Allied Biomedical Corp. for the device "DURALASTIC ANATOMICAL MALAR IMPLANTS". The FDA issued a decision of Substantially Equivalent on July 18, 1997. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Allied Biomedical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1997
Date Received
April 23, 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 Allied Biomedical Corp.

  • K982051 — KELOCATE SHEETING (August 5, 1998)
  • K971478 — DURALASTIC ANATOMICAL CHIN IMPLANTS (July 18, 1997)
  • K971481 — DURALASTIC ANATOMICAL NASAL IMPLANTS (July 18, 1997)
  • K971480 — DURALASTIC I AND DURALASTIC II (May 28, 1997)
  • K955368 — DURALASTIC I (February 8, 1996)
  • K955370 — DURALASTIC II (February 8, 1996)
  • K955433 — DURALASTIC SILICONE TUBING (January 26, 1996)
  • K954413 — KELOCOTE (November 29, 1995)

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