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510(k) K871072

OMEGA NASAL SEPTAL BUTTON by Omega Silicone, Inc. — Product Code LFB

K871072 is an FDA 510(k) premarket notification submitted by Omega Silicone, Inc. for the device "OMEGA NASAL SEPTAL BUTTON". The FDA issued a decision of Substantially Equivalent on June 8, 1987. The device falls under product code LFB (Button, Nasal Septal), a Class U device. Omega Silicone, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1987
Date Received
March 18, 1987
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 by Omega Silicone, Inc.

  • K871070 — OMEGA SILICONE CHIN IMPLANT (May 11, 1987)
  • K871073 — OMEGA BIVALVE NASAL SPLINTS (May 11, 1987)
  • K871071 — OMEGA DORSAL COLUMELLA IMPLANTS (April 13, 1987)
  • K871074 — OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR (April 10, 1987)

Other clearances for product code LFB

  • K131745 — BLOM-SINGER SEPTAL PERFORATION PROSTHESIS (September 17, 2013)
  • K013696 — SILMED NASAL SEPTAL BUTTON (November 28, 2001)
  • 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)
  • 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