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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Tracheal Tube
510(k) Number K950318
Device Name FLEX BLUE
Applicant
KING SYSTEMS CORP.
15011 HERRIMAN BLVD.
P.O. BOX 1138
NOBLESVILLE,  IN  46060
Applicant Contact MICHAEL A LEAGRE
Correspondent
KING SYSTEMS CORP.
15011 HERRIMAN BLVD.
P.O. BOX 1138
NOBLESVILLE,  IN  46060
Correspondent Contact MICHAEL A LEAGRE
Regulation Number868.5770
Classification Product Code
CBH  
Date Received01/26/1995
Decision Date 02/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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