510(k) K897005

BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE by Helix Medical, Inc. — Product Code JOH

K897005 is an FDA 510(k) premarket notification submitted by Helix Medical, Inc. for the device "BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE". The FDA issued a decision of Substantially Equivalent on March 16, 1990. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Helix Medical, Inc. has at least 10 other 510(k) clearances on record.