TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM

Esophagoscope (flexible Or Rigid)

VISION-SCIENCES, INC.

The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Tne-2000 Esophagoscope With Ecs-d Endosheath System.

Pre-market Notification Details

Device IDK031786
510k NumberK031786
Device Name:TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
ClassificationEsophagoscope (flexible Or Rigid)
Applicant VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer,  MA  01432
ContactPamela Papineau
CorrespondentPamela Papineau
VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer,  MA  01432
Product CodeEOX  
CFR Regulation Number874.4710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-10
Decision Date2003-08-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994394631 K031786 000
20613994394570 K031786 000
20613994394563 K031786 000
00763000034238 K031786 000

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