510(k) K900457

CUFFED LINDER NASOTRACHEAL AIRWAY by Polamedco, Inc. — Product Code BTR

K900457 is an FDA 510(k) premarket notification submitted by Polamedco, Inc. for the device "CUFFED LINDER NASOTRACHEAL AIRWAY". The FDA issued a decision of Substantially Equivalent on April 16, 1990. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Polamedco, Inc. has at least 10 other 510(k) clearances on record.