FRONTAL SINUS TREPHINATION CANNULA— 510(k) K994262

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K994262 for FRONTAL SINUS TREPHINATION CANNULA, Substantially Equivalent on 2000-02-08. Applicant: Xomed, Inc.. Device class: 1.

Clearance details

Applicant: Xomed, Inc.
Product code: Code KAM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1999-12-17
Decision date: 2000-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KAM

K110687 — RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)2011-10-07
K093594 — MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER2010-03-03
K083574 — RELIEVA STRATUS MICROFLOW SPACER2009-01-29
K072891 — SINUS SPACER2008-03-19
K073041 — RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER2008-03-11

More clearances from Xomed, Inc.

K002395 — MODEL 30 CLASSIC PNEUMATONOMETER2000-12-11
K002987 — REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE2000-12-04
K002828 — XPS NITRO SYSTEM2000-10-17
K002897 — TITANIUM MIDDLE EAR PROSTHESES2000-10-11
K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES2000-06-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.