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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 K132795
Device Name CYBERWAND STERILE PROBE SET
Applicant
Cybersonics, Inc.
5325 Kuhl Rd.
Erie,  PA  16510
Applicant Contact LORI COLVIN
Correspondent
Cybersonics, Inc.
5325 Kuhl Rd.
Erie,  PA  16510
Correspondent Contact LORI COLVIN
Regulation Number876.4480
Classification Product Code
FFK  
Date Received09/06/2013
Decision Date 11/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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