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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lithotriptor, electro-hydraulic
510(k) Number K120303
Model CW-USLSA
Device Name CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
Original Applicant
CYBERSONICS, INC.
5325 kuhl rd.
erie,  PA  16510
Original Contact lori colvin
Regulation Number876.4480
Classification Product Code
FFK  
Date Received02/13/2012
Decision Date 06/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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