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BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K930105
510(k) Type
Traditional
Applicant
HELIX MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/17/1993
Days to Decision
126 days
Submission Type
Summary

BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K930105
510(k) Type
Traditional
Applicant
HELIX MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/17/1993
Days to Decision
126 days
Submission Type
Summary