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BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K130736
510(k) Type
Traditional
Applicant
HELIX MEDICAL, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2013
Days to Decision
274 days
Submission Type
Summary

BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K130736
510(k) Type
Traditional
Applicant
HELIX MEDICAL, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2013
Days to Decision
274 days
Submission Type
Summary