VISION SCIENCES ENDOSHEATH SYSTEM

Nasopharyngoscope (flexible Or Rigid)

VISION-SCIENCES, INC.

The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision Sciences Endosheath System.

Pre-market Notification Details

Device IDK012543
510k NumberK012543
Device Name:VISION SCIENCES ENDOSHEATH SYSTEM
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer,  MA  01432
ContactPamela Papineu
CorrespondentPamela Papineu
VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer,  MA  01432
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-07
Decision Date2002-07-15
Summary:summary

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