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SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080439
510(k) Type
Special
Applicant
MALLINCKRODT DEVELOPPEMENT FRANCE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/16/2008
Days to Decision
87 days
Submission Type
Summary

SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080439
510(k) Type
Special
Applicant
MALLINCKRODT DEVELOPPEMENT FRANCE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/16/2008
Days to Decision
87 days
Submission Type
Summary