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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 K012485
Device Name MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE
Applicant
KING SYSTEMS CORP.
15011 HERRIMAN BLVD.
P.O. BOX 1138
NOBLESVILLE,  IN  46060
Applicant Contact CHARLES A BURT
Correspondent
KING SYSTEMS CORP.
15011 HERRIMAN BLVD.
P.O. BOX 1138
NOBLESVILLE,  IN  46060
Correspondent Contact CHARLES A BURT
Regulation Number868.5260
Classification Product Code
CAH  
Date Received08/02/2001
Decision Date 10/09/2001
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
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