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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 K063501
Device Name KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US
Applicant
MALLINCKRODT DEVELOPPEMENT FRANCE
4280 HACIENDA DR.
PLEASANTON,  CA  94588
Applicant Contact JAMES BONDS
Correspondent
MALLINCKRODT DEVELOPPEMENT FRANCE
4280 HACIENDA DR.
PLEASANTON,  CA  94588
Correspondent Contact JAMES BONDS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received11/20/2006
Decision Date 04/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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