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510(k) K971481

DURALASTIC ANATOMICAL NASAL IMPLANTS by Allied Biomedical Corp. — Product Code FZE

K971481 is an FDA 510(k) premarket notification submitted by Allied Biomedical Corp. for the device "DURALASTIC ANATOMICAL NASAL IMPLANTS". The FDA issued a decision of Substantially Equivalent on July 18, 1997. The device falls under product code FZE (Prosthesis, Nose, Internal), a Class II device regulated under 21 CFR 878.3680. 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
Prosthesis, Nose, Internal
Device Class
Class II
Regulation Number
878.3680
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)
  • K971479 — DURALASTIC ANATOMICAL MALAR 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 FZE

  • K241253 — Medicon Epiplating System (December 12, 2024)
  • K161548 — Osseointegrated Fixtures (December 1, 2016)
  • K090803 — HANSON MEDICAL FACIAL IMPLANTS (June 30, 2010)
  • K090630 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) (June 2, 2009)
  • K071018 — MONARCH NASAL IMPLANT (May 25, 2007)
  • K041690 — MONARCH NASAL IMPLANT (February 11, 2005)
  • K021418 — AART NASAL IMPLANT (July 2, 2002)
  • K992242 — PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (November 22, 1999)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K982753 — SEARE BIOMEDICAL NASAL IMPLANTS (September 30, 1998)

FDA data resources