FDA 510(k) Applications Submitted by HELIX MEDICAL, LLC

FDA 510(k) Number Submission Date Device Name Applicant
K082206 08/05/2008 BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES HELIX MEDICAL, LLC
K093258 10/19/2009 BLOM-SINGER INDWELLING TEP OCCLUDER HELIX MEDICAL, LLC
K131745 06/13/2013 BLOM-SINGER SEPTAL PERFORATION PROSTHESIS HELIX MEDICAL, LLC
K130736 03/18/2013 BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS HELIX MEDICAL, LLC


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