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BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081440
510(k) Type
Traditional
Applicant
SMITHS MEDICAL ASD, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/12/2008
Days to Decision
113 days
Submission Type
Summary

BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081440
510(k) Type
Traditional
Applicant
SMITHS MEDICAL ASD, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/12/2008
Days to Decision
113 days
Submission Type
Summary