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PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K980466
510(k) Type
Traditional
Applicant
SIMS PORTEX, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/24/1998
Days to Decision
18 days
Submission Type
Summary

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K980466
510(k) Type
Traditional
Applicant
SIMS PORTEX, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/24/1998
Days to Decision
18 days
Submission Type
Summary