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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K052637
Device Name THEROX INFUSION CATHETER, MODEL INCA-1
Original Applicant
THEROX, INC.
2400 michelson dr.
irvine,  CA  92612 -1310
Original Contact david w mullis jr.
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/26/2005
Decision Date 03/08/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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