FDA Product Code LRQ: Tracheostomy And Nasal Suctioning Kit

This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.

Leading manufacturers include Automatic Liquid Packaging, Inc., Contour Fabricators of Florida, Inc. and Medcare Medical Group, Inc..