FDA 510(k) Application Details - K072422

Device Classification Name Lithotriptor, Electro-Hydraulic

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510(K) Number K072422
Device Name Lithotriptor, Electro-Hydraulic
Applicant CYBERSONICS, INC.
5368 KUHL RD.
ERIE, PA 16510-4703 US
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Contact WILLIAM A STOLL
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Regulation Number 876.4480

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Classification Product Code FFK
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Date Received 08/28/2007
Decision Date 10/24/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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