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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
Device Name OXTI INFLATION DEVICE
Original Applicant
OXTI CORPORATION
7128 staffordshire street
houston,  TX  77030
Original Contact joseph j chang
Regulation Number870.1650
Classification Product Code
MAV  
Date Received07/20/2012
Decision Date 12/14/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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