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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
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