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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 K002084
Device Name MICROVASIVE LITHOTRIPTOR FLEXPROBE II
Applicant
Boston Scientific Corp
One Boston Scientific Pl.
Natick,,  MA  01760
Applicant Contact ROBERT J MICHALIK
Correspondent
Boston Scientific Corp
One Boston Scientific Pl.
Natick,,  MA  01760
Correspondent Contact ROBERT J MICHALIK
Regulation Number876.4480
Classification Product Code
FFK  
Date Received07/10/2000
Decision Date 07/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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