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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Tracheal Tube, Inflatable
510(k) Number K113644
Device Name PILOT TUBE REPAIR KIT
Applicant
Instrumentation Industries, Inc.
2990 Industrial Blvd.
Bethel Park,  PA  15102
Applicant Contact DORIS F WALTER
Correspondent
Instrumentation Industries, Inc.
2990 Industrial Blvd.
Bethel Park,  PA  15102
Correspondent Contact DORIS F WALTER
Regulation Number868.5750
Classification Product Code
BSK  
Date Received12/12/2011
Decision Date 01/26/2012
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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