MICROVASIVE LITHOTRIPTOR FLEXPROBE II


definition

Device Classification Name

lithotriptor, electro-hydraulic

510(k) Number K002084
Device Name MICROVASIVE LITHOTRIPTOR FLEXPROBE II
Original Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick, 
MA 
01760

Original Contact robert j michalik
Regulation Number 876.4480
Classification Product Code
FFK  
Date Received 07/10/2000
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