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SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123614
510(k) Type
Traditional
Applicant
TRUDELL MEDICAL INTL.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
3/11/2013
Days to Decision
108 days
Submission Type
Summary

SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123614
510(k) Type
Traditional
Applicant
TRUDELL MEDICAL INTL.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
3/11/2013
Days to Decision
108 days
Submission Type
Summary