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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 K052135
Device Name CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
Applicant
CYBERSONICS, INC.
5368 KUHL RD.
ERIE,  PA  16510 -4703
Applicant Contact WILLIAM A STOLL
Correspondent
CYBERSONICS, INC.
5368 KUHL RD.
ERIE,  PA  16510 -4703
Correspondent Contact WILLIAM A STOLL
Regulation Number876.4480
Classification Product Code
FFK  
Date Received08/05/2005
Decision Date 12/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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