510(k) K993786

RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY by Rusch Intl. — Product Code BTR

K993786 is an FDA 510(k) premarket notification submitted by Rusch Intl. for the device "RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY". The FDA issued a decision of Substantially Equivalent on Feb 2, 2000. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Rusch Intl. has at least 10 other 510(k) clearances on record.