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510(k) K902283

THE NAUTILUS NASAL IMPLANT by Applied Biomaterial Technologies — Product Code FZE

K902283 is an FDA 510(k) premarket notification submitted by Applied Biomaterial Technologies for the device "THE NAUTILUS NASAL IMPLANT". The FDA issued a decision of Substantially Equivalent on August 14, 1990. The device falls under product code FZE (Prosthesis, Nose, Internal), a Class II device regulated under 21 CFR 878.3680. Applied Biomaterial Technologies has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1990
Date Received
May 22, 1990
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 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)
  • K902284 — ZYMALAR IMPLANT (September 12, 1990)

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