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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K983817
Device Name BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
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 Number868.5260
Classification Product Code
CAH  
Date Received10/29/1998
Decision Date 03/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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