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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Oropharyngeal, Anesthesiology
510(k) Number K033189
Device Name KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
Applicant
King Systems Corp.
15011 Herriman Blvd.
Noblesville,  IN  46060
Applicant Contact TOM MCGRAIL
Correspondent
King Systems Corp.
15011 Herriman Blvd.
Noblesville,  IN  46060
Correspondent Contact TOM MCGRAIL
Regulation Number868.5110
Classification Product Code
CAE  
Date Received10/01/2003
Decision Date 05/04/2004
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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