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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, balloon inflation
510(K) Number K122152
Model AT-02003-01
Device Name OXTI INFLATION DEVICE
Applicant
OXTI CORPORATION
7128 staffordshire street
houston,  TX  77030
Contact joseph j chang
Regulation Number870.1650
Classification Product Code
MAV  
Date Received07/20/2012
Decision Date 12/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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