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510(k) K013696

SILMED NASAL SEPTAL BUTTON by Silmed, Inc. — Product Code LFB

K013696 is an FDA 510(k) premarket notification submitted by Silmed, Inc. for the device "SILMED NASAL SEPTAL BUTTON". The FDA issued a decision of Substantially Equivalent on November 28, 2001. The device falls under product code LFB (Button, Nasal Septal), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2001
Date Received
November 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Button, Nasal Septal
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

Other clearances for product code LFB

  • K131745 — BLOM-SINGER SEPTAL PERFORATION PROSTHESIS (September 17, 2013)
  • K982667 — MICROMEDICS NASAL SEPTAL BUTTON (November 24, 1998)
  • K972060 — NASAL SEPTAL BUTTON (July 3, 1997)
  • K920994 — HOOD NASAL SEPTAL BUTTON (May 15, 1992)
  • K901366 — INVOTEC SEPTAL BUTTON (June 14, 1990)
  • K871072 — OMEGA NASAL SEPTAL BUTTON (June 8, 1987)
  • K871200 — CUI NASAL SEPTUM BUTTON (April 15, 1987)
  • K862497 — MICROTEK SEPTAL BUTTON (July 14, 1986)
  • K850492 — NASAL SEPTAL BUTTON (March 7, 1985)
  • K822637 — NASAL SEPTAL BUTTONS (September 28, 1982)

FDA data resources