510(k) K935842

RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE by Rusch, Inc. — Product Code BTR

K935842 is an FDA 510(k) premarket notification submitted by Rusch, Inc. for the device "RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE". The FDA issued a decision of Substantially Equivalent on May 23, 1995. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Rusch, Inc. has at least 10 other 510(k) clearances on record.