Home / 510(k) Clearances / K972060

510(k) K972060

NASAL SEPTAL BUTTON by Boston Medical Products, Inc. — Product Code LFB

K972060 is an FDA 510(k) premarket notification submitted by Boston Medical Products, Inc. for the device "NASAL SEPTAL BUTTON". The FDA issued a decision of Substantially Equivalent on July 3, 1997. The device falls under product code LFB (Button, Nasal Septal), a Class U device. Boston Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1997
Date Received
June 2, 1997
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 Boston Medical Products, Inc.

  • K091135 — RUTTER SUPRA STOMAL STENTS (September 14, 2009)
  • K972317 — MONTGOMERY THYROPLASTY IMPLANT SYSTEM (September 18, 1997)
  • K972459 — RHINOCELL NASAL PACKINGS (August 4, 1997)
  • K972096 — BIVALVE NASAL SPLINT (July 15, 1997)
  • K972078 — POST-STOP EPISTAXIS CATHETER (July 10, 1997)
  • K972092 — NASAL AIRWAY SPLINT (July 8, 1997)
  • K972151 — DOYLE COMBO NASAL AIRWAY SPLINT (July 7, 1997)
  • K972082 — CUSTOM NASAL SPLINT (July 3, 1997)
  • K972077 — EPI-STOP EPISTAXIS CATHETER (June 26, 1997)
  • K972076 — EPI-MAX EPISTAXIS CATHETER (June 26, 1997)

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)
  • 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