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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tube, tracheal (w/wo connector)
510(k) Number K120985
Model 13220,13221,13222,13223,13224
Device Name KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
Original Applicant
KIMBERLY-CLARK CORP.
1400 holcomb bridge rd.
roswell,  GA  30076
Original Contact marcia johnson
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/02/2012
Decision Date 12/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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