Nasal Septal Buttons

FDA 510(k) K822637 · Abco Dealers, Inc.

Substantially Equivalent

510(k) numberK822637

Submission

Device name
Nasal Septal Buttons
Applicant
Abco Dealers, Inc.
Mchenry, IL, US
Received
August 31, 1982
Decision date
September 28, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LFB – Button, Nasal Septal
Device class
Unclassified
Implant
Yes

Other 510(k)s with product code LFB

510(k)DeviceApplicantDecision
K131745Blom-Singer Septal Perforation ProsthesisLFB · Traditional Helix Medical, LLC09/17/2013SE
K013696Silmed Nasal Septal ButtonLFB · Traditional Silmed, Inc.11/28/2001SE
K982667Micromedics Nasal Septal ButtonLFB · Traditional Micromedics, Inc.11/24/1998SE
K972060Nasal Septal ButtonLFB · Traditional Boston Medical Products, Inc.07/03/1997SE
K920994Hood Nasal Septal ButtonLFB · Traditional Hood Laboratories05/15/1992SE
K901366Invotec Septal ButtonLFB · Traditional Invotec International, Inc.06/14/1990SE
K871072Omega Nasal Septal ButtonLFB · Traditional Omega Silicone, Inc.06/08/1987SE
K871200Cui Nasal Septum ButtonLFB · Traditional Cox-Uphuff Intl.04/15/1987SE
K862497Microtek Septal ButtonLFB · Traditional Microtek Medical, Inc.07/14/1986SE
K850492Nasal Septal ButtonLFB · Traditional Santa Barbara Medco, Inc.03/07/1985SE

More from Santa Barbara Medco, Inc.

510(k)DeviceDecision
K905025Digital Thermometer KitsFLL · Traditional 02/07/1991SE
K882304Digital Thermometer Sheaths (Oral and Rectal)FLL · Traditional 07/12/1988SE
K880892Blood Collecting Needle and HoldersFMI · Traditional 04/21/1988SE
K880894Allergist SyringesFMF · Traditional 03/31/1988SE
K872875Stretch Gauze BandagesNAD · Traditional 09/04/1987SE
K872874Microscope Cover GlassesKES · Traditional 08/10/1987SE
K872797Non-Skid Shoe CoversFXP · Traditional 08/04/1987SE
K871465Thermometer SheathsFLL · Traditional 05/11/1987SE
K862726Disposable Shoe Covers and Nurses CapsFXP · Traditional 08/01/1986SE
K862111Armboards, Reusable and Disposable · Traditional 07/08/1986SE

Questions and answers

When was Nasal Septal Buttons cleared by the FDA?

Nasal Septal Buttons (K822637) received a 510(k) decision of Substantially Equivalent on September 28, 1982, 28 days after the submission was received.

What is the product code of K822637?

The FDA product code is LFB – Button, Nasal Septal, a Unclassified device.