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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, straight
510(k) Number K122078
Device Name LOFRIC PRIMO, LOFRIC HYDRO-KIT
Original Applicant
ASTRA TECH, INC.
11234 el camino real, ste 200
san diego,  CA  92130
Original Contact allison c komiyama
Regulation Number876.5130
Classification Product Code
EZD  
Date Received07/16/2012
Decision Date 10/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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