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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 K113333
Device Name KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS
Applicant
Kimberly-Clark Corporation
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Applicant Contact MARCIA JOHNSON
Correspondent
Kimberly-Clark Corporation
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Correspondent Contact MARCIA JOHNSON
Regulation Number868.5730
Classification Product Code
BTR  
Date Received11/14/2011
Decision Date 05/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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