FDA 510(k) Application Details - K002084

Device Classification Name Lithotriptor, Electro-Hydraulic

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510(K) Number K002084
Device Name Lithotriptor, Electro-Hydraulic
Applicant BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick, MA 01760 US
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Contact ROBERT J MICHALIK
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Regulation Number 876.4480

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Classification Product Code FFK
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Date Received 07/10/2000
Decision Date 07/19/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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