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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 K963344
Device Name DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
Applicant
Vision-Sciences, Inc.
6 Strathmore Rd.
Natick,  MA  01760
Applicant Contact PAMELA PAPINEAU
Correspondent
Vision-Sciences, Inc.
6 Strathmore Rd.
Natick,  MA  01760
Correspondent Contact PAMELA PAPINEAU
Regulation Number876.1500
Classification Product Code
FAM  
Date Received08/26/1996
Decision Date 11/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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