VISION SYSTEM UPPER G.I. EXDOSCOPE

Gastroscope And Accessories, Flexible/rigid

VISION-SCIENCES, INC.

The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision System Upper G.i. Exdoscope.

Pre-market Notification Details

Device IDK943715
510k NumberK943715
Device Name:VISION SYSTEM UPPER G.I. EXDOSCOPE
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick,  MA  01760
ContactDebbie Iampietro
CorrespondentDebbie Iampietro
VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick,  MA  01760
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-01
Decision Date1995-02-24

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