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BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082206
510(k) Type
Special
Applicant
HELIX MEDICAL, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/4/2008
Days to Decision
30 days
Submission Type
Summary

BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082206
510(k) Type
Special
Applicant
HELIX MEDICAL, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/4/2008
Days to Decision
30 days
Submission Type
Summary