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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 K932843
Device Name FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH
Applicant
VISION-SCIENCES, INC.
6 STRATHMORE RD.
NATICK,  MA  01760
Applicant Contact DEBBIE IAMPIETRO
Correspondent
VISION-SCIENCES, INC.
6 STRATHMORE RD.
NATICK,  MA  01760
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number876.1500
Classification Product Code
FAM  
Subsequent Product Code
FET  
Date Received06/11/1993
Decision Date 02/14/1994
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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