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PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K040014
510(k) Type
Traditional
Applicant
PORTEX LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
2/13/2004
Days to Decision
51 days
Submission Type
Summary

PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K040014
510(k) Type
Traditional
Applicant
PORTEX LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
2/13/2004
Days to Decision
51 days
Submission Type
Summary