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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 K031786
FOIA Releasable 510(k) K031786
Device Name TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
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 Received06/10/2003
Decision Date 08/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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