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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
Device Name KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Applicant Contact MARCIA JOHNSON
Correspondent
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Correspondent Contact MARCIA JOHNSON
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/02/2012
Decision Date 12/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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