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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K053560
Device Name MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
Applicant
VISION-SCIENCES, INC.
5 WHITCOMB AVE.
AYER,  MA  01432
Applicant Contact PAMELA PAPINEAU
Correspondent
VISION-SCIENCES, INC.
5 WHITCOMB AVE.
AYER,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received12/21/2005
Decision Date 03/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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