510(k) K955564

RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE by Rusch, Inc. — Product Code JOH

K955564 is an FDA 510(k) premarket notification submitted by Rusch, Inc. for the device "RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE". The FDA issued a decision of Substantially Equivalent on June 28, 1996. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Rusch, Inc. has at least 10 other 510(k) clearances on record.