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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name media,coupling,ultrasound
510(k) Number K121311
Device Name THIXO-GEL ULTRASOUND SPRAY
Original Applicant
CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH
2670 leavenworth street
san francisco,  CA  94133
Original Contact christina bernstein
Regulation Number892.1570
Classification Product Code
MUI  
Date Received05/01/2012
Decision Date 08/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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