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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sigmoidoscope and accessories, flexible/rigid
510(k) Number K921690
Device Name FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM
Applicant
VISION-SCIENCES, INC.
6 STRATHMORE RD.
NATICK,  MA  01760
Applicant Contact ALAN I WEST
Correspondent
VISION-SCIENCES, INC.
6 STRATHMORE RD.
NATICK,  MA  01760
Correspondent Contact ALAN I WEST
Regulation Number876.1500
Classification Product Code
FAM  
Subsequent Product Code
ODB  
Date Received04/08/1992
Decision Date 10/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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