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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 K021634
Device Name KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
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 Received05/17/2002
Decision Date 01/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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