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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Ultrasonic
510(k) Number K171024
Device Name ShockPulse-SE Lithotripsy System
Applicant
Cybersonics, Inc.
Knowledge Park, 5340 Fryling Rd., Suite 101
Erie,  PA  16510
Applicant Contact Samradni Patil
Correspondent
Cybersonics, Inc.
Knowledge Park, 5340 Fryling Rd., Suite 101
Erie,  PA  16510
Correspondent Contact Samradni Patil
Regulation Number876.4480
Classification Product Code
FEO  
Date Received04/05/2017
Decision Date 08/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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