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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K080439
Device Name SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE
Applicant
Mallinckrodt Developpement France
6135 Gunbarell Ave.
Boulder,  CO  80301
Applicant Contact TINA DREILING
Correspondent
Mallinckrodt Developpement France
6135 Gunbarell Ave.
Boulder,  CO  80301
Correspondent Contact TINA DREILING
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/19/2008
Decision Date 05/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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