510(k) K082206

BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES by Helix Medical, LLC — Product Code EWL

K082206 is an FDA 510(k) premarket notification submitted by Helix Medical, LLC for the device "BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES". The FDA issued a decision of Substantially Equivalent on September 4, 2008. The device falls under product code EWL (Prosthesis, Laryngeal (Taub)), a Class II device regulated under 21 CFR 874.3730. Helix Medical, LLC has at least 10 other 510(k) clearances on record.