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510(k) K850492

NASAL SEPTAL BUTTON by Santa Barbara Medco, Inc. — Product Code LFB

K850492 is an FDA 510(k) premarket notification submitted by Santa Barbara Medco, Inc. for the device "NASAL SEPTAL BUTTON". The FDA issued a decision of Substantially Equivalent on March 7, 1985. The device falls under product code LFB (Button, Nasal Septal), a Class U device. Santa Barbara Medco, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1985
Date Received
February 8, 1985
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 Santa Barbara Medco, Inc.

  • K842483 — SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC (August 31, 1984)
  • K823921 — PHYSICIANS CHOICE SILICONE EAR PUTTY (March 28, 1983)
  • K821187 — MEDCO CUSTOM EAR PROTECTOR MOLD KIT (May 27, 1982)
  • K812069 — BORES* DEPTH GAUGE (August 31, 1981)
  • K812071 — RK IV SURGICAL BLADES (August 31, 1981)
  • K812070 — BORES* ADJUSTABLE BLADE HOLDER (August 18, 1981)
  • K802638 — OTOLOGICAL VENTILATION TUBES (November 12, 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)
  • K871200 — CUI NASAL SEPTUM BUTTON (April 15, 1987)
  • K862497 — MICROTEK SEPTAL BUTTON (July 14, 1986)
  • K822637 — NASAL SEPTAL BUTTONS (September 28, 1982)

FDA data resources