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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Absorber, Carbon-Dioxide
510(k) Number K951093
Device Name KAB SYSTEM
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 Number868.5310
Classification Product Code
BSF  
Date Received03/09/1995
Decision Date 03/24/1995
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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