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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 K033186
Device Name KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
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 04/14/2004
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
Recalls CDRH Recalls
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