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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, radiation therapy, charged-particle, medical
510(k) Number K112969
Device Name AIR-BAG SYSTEM
Original Applicant
NIIGATA MECHATRONICS CO., LTD.
3268-18, shimami-cho, kita-ku
niigata-city,  JP 950-3102
Original Contact toshiya nimonji
Regulation Number892.5050
Classification Product Code
LHN  
Date Received10/05/2011
Decision Date 03/14/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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