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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
Applicant
OXTI CORPORATION
7128 STAFFORDSHIRE STREET
HOUSTON,  TX  77030
Applicant Contact JOSEPH J CHANG
Correspondent
OXTI CORPORATION
7128 STAFFORDSHIRE STREET
HOUSTON,  TX  77030
Correspondent 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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