510(k) K945288

INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE by Helix Medical, Inc. — Product Code EWL

K945288 is an FDA 510(k) premarket notification submitted by Helix Medical, Inc. for the device "INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE". The FDA issued a decision of Substantially Equivalent on December 2, 1994. The device falls under product code EWL (Prosthesis, Laryngeal (Taub)), a Class II device regulated under 21 CFR 874.3730. Helix Medical, Inc. has at least 10 other 510(k) clearances on record.