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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophagoscope (Flexible Or Rigid)
510(k) Number K071903
Device Name ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
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 Number874.4710
Classification Product Code
EOX  
Date Received07/10/2007
Decision Date 08/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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