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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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