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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 K112915
Device Name SPIRTIUS CUFF INFLATION SYRINGE
Applicant
SPIRITUS TECHNOLOGIES LLC
12005 W. 100TH TERRACE
LENEXA,  KS  66215
Applicant Contact BRANDON W CLOSE
Correspondent
SPIRITUS TECHNOLOGIES LLC
12005 W. 100TH TERRACE
LENEXA,  KS  66215
Correspondent Contact BRANDON W CLOSE
Regulation Number868.5750
Classification Product Code
BSK  
Date Received10/03/2011
Decision Date 05/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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