Home / 510(k) Clearances / K871200

510(k) K871200

CUI NASAL SEPTUM BUTTON by Cox-Uphuff Intl. — Product Code LFB

K871200 is an FDA 510(k) premarket notification submitted by Cox-Uphuff Intl. for the device "CUI NASAL SEPTUM BUTTON". The FDA issued a decision of Substantially Equivalent on April 15, 1987. The device falls under product code LFB (Button, Nasal Septal), a Class U device. Cox-Uphuff Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1987
Date Received
March 25, 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 Cox-Uphuff Intl.

  • K874276 — CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER (December 2, 1987)
  • K874342 — LIGATURE CARRIER/PACKER, HYDROXYLAPATITE (November 13, 1987)
  • K873470 — TEMPLATE (September 8, 1987)
  • K865056 — CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER (May 22, 1987)
  • K865033 — BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER (January 12, 1987)
  • K854339 — CUI CHIN SIZER (November 15, 1985)
  • K853945 — CUI RHINOPLASTY IMPLANTS (October 18, 1985)
  • K831566 — CUI MAMMARY PROTHESIS SIZER (August 12, 1983)
  • K813394 — DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM (January 22, 1982)
  • K802214 — COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM (October 23, 1980)

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)
  • K871072 — OMEGA NASAL SEPTAL BUTTON (June 8, 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