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510(k) K801074

STRAITH NASAL IMPLANT by Surgical Technology Laboratories, Inc. — Product Code FZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1980
Date Received
May 6, 1980
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

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  • K983754 — STANDARD CHIN (November 20, 1998)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K964443 — SURGIFORM ANATOMICAL MALAR (December 20, 1996)
  • K840835 — STRAITH DRAIN INSERTER (April 23, 1984)
  • K831078 — STRAITH ORAL AIRWAY (June 24, 1983)
  • K801072 — STRAITH NASAL SPLINT (June 17, 1980)
  • K801075 — STRAITH CHISEL FORCEPS (May 20, 1980)

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)